Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
Russian Federation
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, 18-70 years of age;
- chronic hepatitis B;
- Hepatitis B Virus (HBV) DNA >100,000 copies/mL.
Exclusion Criteria:
- previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
- evidence of decompensated liver disease;
- history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- coinfection with hepatitis A, C or D, or HIV.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peginterferon Alfa-2a
Arm Description
Outcomes
Primary Outcome Measures
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.
Secondary Outcome Measures
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.
Mean Change in Laboratory Parameters (ALT Levels)
Mean Change in Laboratory parameters (ALT levels) is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487747
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Official Title
PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (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 single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon Alfa-2a
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 48 weeks
Primary Outcome Measure Information:
Title
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
Description
This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.
Time Frame
Week 96
Title
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
Description
This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
Description
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.
Time Frame
Week 96
Title
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
Description
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.
Time Frame
Week 96
Title
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Description
All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.
Time Frame
Up to Week 96
Title
Mean Change in Laboratory Parameters (ALT Levels)
Description
Mean Change in Laboratory parameters (ALT levels) is reported.
Time Frame
From Screening (Day 0) to Week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-70 years of age;
chronic hepatitis B;
Hepatitis B Virus (HBV) DNA >100,000 copies/mL.
Exclusion Criteria:
previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
evidence of decompensated liver disease;
history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
coinfection with hepatitis A, C or D, or HIV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620020
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
City
Irkutsk
ZIP/Postal Code
664047
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
City
Moscow
ZIP/Postal Code
121293
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603022
Country
Russian Federation
City
Novokuznetsk
ZIP/Postal Code
654063
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630016
Country
Russian Federation
City
Rostov-na-donu
ZIP/Postal Code
344010
Country
Russian Federation
City
Samara
ZIP/Postal Code
443021
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625002
Country
Russian Federation
City
UFA
ZIP/Postal Code
450000
Country
Russian Federation
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
City
Yakutsk
ZIP/Postal Code
677000
Country
Russian Federation
12. IPD Sharing Statement
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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
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