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Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection
This study has been completed.
First Received: April 26, 2002   Last Updated: July 20, 2006   History of Changes
Sponsor: Achillion Pharmaceuticals
Information provided by: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034359
  Purpose

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 Intervention Phase
Hepatitis B, Chronic
Drug: ACH-126, 443 (beta-L-Fd4C)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Estimated Enrollment: 120
Study Start Date: February 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034359

Locations
Bulgaria
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
Investigators
Investigator: Lisa M Dunkle, M.D. Achillion Pharmaceuticals
  More Information

Additional Information:
No publications provided

Study ID Numbers: ACH443-003
Study First Received: April 26, 2002
Last Updated: July 20, 2006
ClinicalTrials.gov Identifier: NCT00034359     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Therapeutic Uses
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on November 25, 2009