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A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Primary Purpose

Hepatitis B, Chronic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

peginterferon alfa-2a [Pegasys]

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, 3 years to <18 years of age at baseline
Positive HBsAg for more than 6 months
Positive HBeAg and detectable HBV DNA at screening
A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
Compensated liver disease (Child-Pugh Class A)
Elevated serum alanine transferase (ALT)
Normal thyroid gland function at screening

Exclusion Criteria:

Subjects with cirrhosis
Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
Known hypersensitivity to peginterferon
Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection
History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B
History or evidence of bleeding from esophageal varices
Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)
History of immunologically mediated disease
Pregnant or lactating females

Sites / Locations

Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition
Johns Hopkins Hospital - Pediatric Gastroenterology
Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology
St. Louis University - Cardinal Glennon Children's Medical Center
Texas Children's Hospital
Seattle Children's Hospital
Womens and Childrens Hospital; Department of Gastroenterology
Royal Children's Hospital; Department of Gastroenterology
Cliniques Universitaires St-Luc
UZ Gent
Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology
University Hospital "St. Marine"; Dept. of Pediatrics
Beijing You An Hospital; Digestive Dept
Beijing 302 Hospital; No. 2 Infectious Disease Section
the First Hospital of Jilin University
Southwest Hospital , Third Military Medical University
The Eighth People's Hospital of Guangzhou
The Third Affiliated Hospital of Sun Yat-Sen University
The First Affilliated Hospital of Kunming Medical College
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke
Rambam Medical Center
Hadassah University Hospital - Ein Kerem
Western Galilee Hospital - Nahariya
Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive
Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii
Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci
Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci
SFI Sceintific Research institute of nutrition of RAMS
SI Sceintific children health center RAMS
FSI Scientific research Institute of children's infections
MC Gepatolog
Kyiv Children's Clinical Infectious Diseases Hospital
SI Institute of the pediatrics, obstetrics and gynecology
Birmingham Children'S Hopsital; Liver Unit
Kings College Hospital NHS Foundation Trust
Imperial College Healthcare Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Arm Label

A Pegasys

B Untreated Control

C Fibrosis non-randomized

Switch

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

Secondary Outcome Measures

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B

HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B

Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B

HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B

The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B

The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Normal ALT at EOT/POP in Groups A and B

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Quantitative Serum ALT Level in Groups A and B

Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBV DNA Level in Groups A and B

Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBV DNA Level in Groups A and B

The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C

The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C

The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population

Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBeAg Seroconversion at EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Loss of HBeAg at EOT in Group C

The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBsAg Seroconversion at EOT in Group C

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Loss of HBsAg at EOT in Group C

The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Normal ALT at EOT in Group C

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With HBV DNA Undetectable at EOT in Group C

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Quantitative Serum ALT Level in Group C

Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBV DNA Level in Group C

Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBV DNA Level in Group C

The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category

AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects analyzed" reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.

Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B

The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B

The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBeAg Level in Groups A and B

Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBsAg Level in Groups A and B

Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBeAg Level in Group C

Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Quantitative HBsAg Level in Group C

Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C

Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Percentage of Participants With >15% Drop in Height Percentile for Age in Group C

The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.

Change From Baseline in Height for Age Z-Score in Groups A and B

The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Weight for Age Z-Score in Groups A and B

The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Height for Age Z-Score in Group C

Change From Baseline in Weight for Age Z-Score in Group C

The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Change From Baseline in Quantitative Serum ALT Level in Groups A and B

The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBeAg Level in Groups A and B

The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBsAg Level in Groups A and B

The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative Serum ALT Level in Group C

The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBeAg Level in Group C

The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Change From Baseline in Quantitative HBsAg Level in Group C

The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group

Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Full Information

NCT ID

NCT01519960

First Posted

December 6, 2011

Last Updated

October 26, 2022

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01519960

Brief Title

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Official Title

A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 11, 2012 (Actual)

Primary Completion Date

July 9, 2015 (Actual)

Study Completion Date

October 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A Pegasys

Arm Type

Experimental

Arm Title

B Untreated Control

Arm Type

No Intervention

Arm Title

C Fibrosis non-randomized

Arm Type

Experimental

Arm Title

Switch

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion

Primary Outcome Measure Information:

Title

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B

Description

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B

Description

The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

Week 48

Title

Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B

Description

The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

Week 48

Title

Percentage of Participants With Normal ALT at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B

Description

Time Frame

Week 48

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

Week 48

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

Week 48

Title

Quantitative Serum ALT Level in Groups A and B

Description

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Quantitative HBV DNA Level in Groups A and B

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBV DNA Level in Groups A and B

Description

Time Frame

Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C

Description

The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBeAg Seroconversion at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With Loss of HBeAg at EOT in Group C

Description

The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

Week 48

Title

Percentage of Participants With HBsAg Seroconversion at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With Loss of HBsAg at EOT in Group C

Description

The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

Week 48

Title

Percentage of Participants With Normal ALT at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With HBV DNA Undetectable at EOT in Group C

Description

Time Frame

Week 48

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

Week 48

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Time Frame

Week 48

Title

Quantitative Serum ALT Level in Group C

Description

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Quantitative HBV DNA Level in Group C

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBV DNA Level in Group C

Description

Time Frame

Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category

Description

Time Frame

Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)

Title

Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B

Description

Time Frame

Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Title

Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B

Description

Time Frame

Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Quantitative HBeAg Level in Groups A and B

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Quantitative HBsAg Level in Groups A and B

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Quantitative HBeAg Level in Group C

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Quantitative HBsAg Level in Group C

Description

Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C

Description

Time Frame

Week 48; FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With >15% Drop in Height Percentile for Age in Group C

Description

The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.

Time Frame

Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Height for Age Z-Score in Groups A and B

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Weight for Age Z-Score in Groups A and B

Description

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Height for Age Z-Score in Group C

Description

Time Frame

Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Weight for Age Z-Score in Group C

Description

The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative Serum ALT Level in Groups A and B

Description

Time Frame

Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBeAg Level in Groups A and B

Description

Time Frame

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBsAg Level in Groups A and B

Description

Time Frame

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative Serum ALT Level in Group C

Description

The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Time Frame

Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBeAg Level in Group C

Description

Time Frame

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Change From Baseline in Quantitative HBsAg Level in Group C

Description

The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Time Frame

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

Baseline, FU Years: 1, 2, 3, 4, 5

Title

Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

Time Frame

FU Week 24 (up to 72 weeks overall)

Title

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Description

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Time Frame

FU Week 24 (up to 72 weeks overall)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, 3 years to <18 years of age at baseline Positive HBsAg for more than 6 months Positive HBeAg and detectable HBV DNA at screening A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis Compensated liver disease (Child-Pugh Class A) Elevated serum alanine transferase (ALT) Normal thyroid gland function at screening Exclusion Criteria: Subjects with cirrhosis Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded Known hypersensitivity to peginterferon Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B History or evidence of bleeding from esophageal varices Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C) History of immunologically mediated disease Pregnant or lactating females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Johns Hopkins Hospital - Pediatric Gastroenterology

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287-5554

Country

United States

Facility Name

Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

St. Louis University - Cardinal Glennon Children's Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Texas Children's Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Womens and Childrens Hospital; Department of Gastroenterology

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Royal Children's Hospital; Department of Gastroenterology

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Cliniques Universitaires St-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

University Hospital "St. Marine"; Dept. of Pediatrics

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Beijing You An Hospital; Digestive Dept

City

Beijing City

ZIP/Postal Code

100069

Country

China

Facility Name

Beijing 302 Hospital; No. 2 Infectious Disease Section

City

Beijing

ZIP/Postal Code

100039

Country

China

Facility Name

the First Hospital of Jilin University

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Southwest Hospital , Third Military Medical University

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

The Eighth People's Hospital of Guangzhou

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

The Third Affiliated Hospital of Sun Yat-Sen University

City

Guangzhou

ZIP/Postal Code

510630

Country

China

Facility Name

The First Affilliated Hospital of Kunming Medical College

City

Kunming

ZIP/Postal Code

650032

Country

China

Facility Name

Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

City

Urumqi (乌鲁木齐)

ZIP/Postal Code

830000

Country

China

Facility Name

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

City

Xi'an

ZIP/Postal Code

710061

Country

China

Facility Name

HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah University Hospital - Ein Kerem

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Western Galilee Hospital - Nahariya

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii

City

Bydgoszcz

ZIP/Postal Code

85-030

Country

Poland

Facility Name

Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci

City

Łodz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

SFI Sceintific Research institute of nutrition of RAMS

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

SI Sceintific children health center RAMS

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

FSI Scientific research Institute of children's infections

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

MC Gepatolog

City

Samara

ZIP/Postal Code

443100

Country

Russian Federation

Facility Name

Kyiv Children's Clinical Infectious Diseases Hospital

City

Kyiv

ZIP/Postal Code

01119

Country

Ukraine

Facility Name

SI Institute of the pediatrics, obstetrics and gynecology

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Birmingham Children'S Hopsital; Liver Unit

City

Birmingham

ZIP/Postal Code

B4 6NH

Country

United Kingdom

Facility Name

Kings College Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Imperial College Healthcare Trust

City

London

ZIP/Postal Code

W2 1PG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29689122

Citation

Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C. Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study. Hepatology. 2018 Nov;68(5):1681-1694. doi: 10.1002/hep.30050. Epub 2018 Oct 8.

Results Reference

derived

Learn more about this trial

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

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