A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Peginterferon alfa-2a

• Registration Number: NCT00436163
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Study Start: 2007-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-08
• Results First Submitted: 2016-08-31
• Results First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Results First Posted: 2016-10-24
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peginterferon Alfa-2a	Peginterferon alfa-2a	Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.

Primary Outcome Measures

Name	Time	Method
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)	Week 72	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	Week 72	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

Name	Time	Method
Number of Participants With HBV-DNA < 400 Copies/mL	Week 72
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants	Week 48 and Week 72	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	Week 48 and Week 72	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	Week 48 and Week 72
Percentage of HBeAg Negative Participants	Week 48 and Week 72	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	Week 48 and Week 72	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.