Trials / Completed
CompletedNCT00034359
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Detailed description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACH-126,443 | |
| DRUG | Lamivudine | |
| DRUG | Placebo |
Timeline
- Start date
- 2002-02-01
- Primary completion
- 2003-01-01
- Completion
- 2003-01-01
- First posted
- 2002-04-29
- Last updated
- 2021-02-18
Locations
3 sites across 2 countries: Bulgaria, Federal Republic of Yugoslavia
Source: ClinicalTrials.gov record NCT00034359. Inclusion in this directory is not an endorsement.