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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034359
Recruitment Status : Completed
First Posted : April 29, 2002
Last Update Posted : February 19, 2014
Information provided by:
Achillion Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: ACH-126, 443 (beta-L-Fd4C) Drug: Lamivudine Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2002
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034359

Clinic of Gastroenterology
Sofia, Bulgaria
Foundation of Gastroenterology
Sofia, Bulgaria
Former Yugoslavia
Clinic Center of Serbia, Institute of Infectious Disease
Belgrade, Former Yugoslavia
Clinic of Novi Sad
Novi Sad, Former Yugoslavia
Sponsors and Collaborators
Achillion Pharmaceuticals
OverallOfficial: Lisa M Dunkle, M.D. Achillion Pharmaceuticals

Additional Information: Identifier: NCT00034359     History of Changes
Other Study ID Numbers: ACH443-003
First Posted: April 29, 2002    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Achillion Pharmaceuticals:
E-antigen positive
Treatment Naive Chronic Hepatitis B, Achillion

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Anti-HIV Agents