Back to resultsA Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult participants, 18-70 years of age;
- HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
- anti-HBs negative;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
Exclusion Criteria:
- Previous antiviral or interferon-based therapy for chronic hepatitis B;
- Evidence of decompensated liver disease;
- Chronic liver disease other than viral hepatitis;
- Co-infection with active hepatitis A, C or D virus;
- Co-infection with human immunodeficiency virus.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peginterferon Alfa-2a
Arm Description
Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Outcomes
Primary Outcome Measures
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Secondary Outcome Measures
Number of Participants With HBV-DNA < 400 Copies/mL
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.
Percentage of Anti-HBs Positive Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.
Mean Alanine Aminotransferase (ALT) Concentrations
Percentage of HBeAg Negative Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.
Percentage of Anti-HBe Positive Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436163
Brief Title
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Official Title
Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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 evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.
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
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon Alfa-2a
Arm Type
Experimental
Arm Description
Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys®
Intervention Description
180 mcg subcutaneously once per week for 48 weeks.
Primary Outcome Measure Information:
Title
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
Description
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Time Frame
Week 72
Title
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
Description
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Number of Participants With HBV-DNA < 400 Copies/mL
Time Frame
Week 72
Title
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
Description
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.
Time Frame
Week 48 and Week 72
Title
Percentage of Anti-HBs Positive Participants
Description
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.
Time Frame
Week 48 and Week 72
Title
Mean Alanine Aminotransferase (ALT) Concentrations
Time Frame
Week 48 and Week 72
Title
Percentage of HBeAg Negative Participants
Description
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.
Time Frame
Week 48 and Week 72
Title
Percentage of Anti-HBe Positive Participants
Description
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.
Time Frame
Week 48 and Week 72
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 participants, 18-70 years of age;
HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
anti-HBs negative;
Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
Exclusion Criteria:
Previous antiviral or interferon-based therapy for chronic hepatitis B;
Evidence of decompensated liver disease;
Chronic liver disease other than viral hepatitis;
Co-infection with active hepatitis A, C or D virus;
Co-infection with human immunodeficiency virus.
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
Tallinn
ZIP/Postal Code
10138
Country
Estonia
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Riga
ZIP/Postal Code
1006
Country
Latvia
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08117
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
12. IPD Sharing Statement
Learn more about this trial
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
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