Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult patients, 18-65 years of age
- HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
- Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)
Exclusion Criteria:
- Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- A medical condition associated with chronic liver disease other than viral hepatitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PEG-IFN alfa-2a (Treatment naïve)
PEG-IFN alfa-2a (YMDD mutant)
Arm Description
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
Secondary Outcome Measures
Percentage of Participants With ALT Normalization At Week 48 and Week 72
Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.
Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.
Percentage of Participants With a Combined Response At Week 48 and Week 72
A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.
Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01519921
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Official Title
An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (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 study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-IFN alfa-2a (Treatment naïve)
Arm Type
Experimental
Arm Description
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Arm Title
PEG-IFN alfa-2a (YMDD mutant)
Arm Type
Experimental
Arm Description
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
Description
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Time Frame
Week 72
Title
Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
Description
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With ALT Normalization At Week 48 and Week 72
Description
Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.
Time Frame
Week 48 and Week 72
Title
Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
Description
Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.
Time Frame
Week 48 and Week 72
Title
Percentage of Participants With a Combined Response At Week 48 and Week 72
Description
A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.
Time Frame
Week 48 and Week 72
Title
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
Description
A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.
Time Frame
Week 48 and Week 72
Title
Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
Description
A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.
Time Frame
Week 48 and Week 72
Title
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
Description
A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.
Time Frame
Week 48 and Week 72
Title
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Description
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.
Time Frame
Up to Week 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, 18-65 years of age
HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)
Exclusion Criteria:
Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
Evidence of decompensated liver disease
A medical condition associated with chronic liver disease other than viral hepatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
14647
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
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