Trials / Completed
CompletedNCT01095835
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
A Multicenter, Randomized, Controlled Study Comparing the Efficacy and Safety of 48 Weeks of 40kD Branched Pegylated Interferon Alfa-2a (PEG-IFN, RO 25-8310) Versus 96 Weeks of PEG-IFN, Alone or in Combination With 100 mg Lamivudine for 48 Weeks in Patients With HBeAg-Negative Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg | PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. |
| DRUG | Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg | PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96. |
| DRUG | Lamivudine (LAM) | Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48. |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2010-03-30
- Last updated
- 2016-11-03
- Results posted
- 2016-11-03
Locations
22 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT01095835. Inclusion in this directory is not an endorsement.