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.
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034359
First received: April 26, 2002
Last updated: February 18, 2014
Last verified: February 2014
  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)
Drug: Lamivudine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Enrollment: 79
Study Start Date: February 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00034359     History of Changes
Other Study ID Numbers: ACH443-003
Study First Received: April 26, 2002
Last Updated: February 18, 2014
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:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014