Trials / Completed
CompletedNCT00686790
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Peginterferon alfa-2b (PegIntron, SCH 54031) | Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks. |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2008-05-30
- Last updated
- 2017-04-06
- Results posted
- 2011-01-17
Source: ClinicalTrials.gov record NCT00686790. Inclusion in this directory is not an endorsement.