Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection - Tabular View

Tracking Information

First Received Date ^ICMJE

April 26, 2002

Last Updated Date

July 20, 2006

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00034359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443 (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic Hepatitis B infection.

Detailed Description

Evaluation of safety and antiviral activity of 3 dose levels of ACH-126, 443 vs. lamivudine and placebo over 12 weeks of treatment in the population described.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

Drug: ACH-126, 443 (beta-L-Fd4C)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults >= 18 years of age
Chronic HBV infection, known to be HbsAg positive >= 6 months
Plasma HBV DNA level >= 100,000 copies/mL
HBe-antigen positive
HIV negative
Basic hematologic and chemistry parameters within acceptable limits (defined in protocol
No need for excluded medications
Subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection.

Exclusion Criteria:

HIV infection
Hepatitis C co-infection
Concurrent systemic antiviral treatment
Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with 3TC for more than 6 months at any time in the past
Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
Alcohol abuse
Pregnancy or breast-feeding
Inability to tolerate oral medication
AST>7.0 times the upper limit of normal
ALT>7.0 times the upper limit of normal
Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Use of any investigational drug.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Former Yugoslavia

Administrative Information

NCT ID ^ICMJE

NCT00034359

Responsible Party

Study ID Numbers ^ICMJE

ACH443-003

Study Sponsor ^ICMJE

Achillion Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Lisa M Dunkle, M.D.

Achillion Pharmaceuticals

Information Provided By

Achillion Pharmaceuticals

Verification Date

September 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP