Phase 4
N=39
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00436163 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: 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) — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peginterferon alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
6 | — |
| PRIMARY Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL |
6 | — |
| SECONDARY Number of Participants With HBV-DNA < 400 Copies/mL |
4 | — |
| SECONDARY Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants |
3; 3 | — |
| SECONDARY Percentage of Anti-HBs Positive Participants |
8; 3 | — |
| SECONDARY Mean Alanine Aminotransferase (ALT) Concentrations |
62.6; 64.5 | — |
| SECONDARY Percentage of HBeAg Negative Participants |
25; 29 | — |
| SECONDARY Percentage of Anti-HBe Positive Participants |
41; 33 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00436163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.