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

This study has been terminated.
(Safety concerns from other studies.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037622
First Posted: May 20, 2002
Last Update Posted: August 19, 2009
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.
Information provided by:
Achillion Pharmaceuticals
  Purpose
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Estimated Enrollment: 100
Study Completion Date: May 2003
Detailed Description:
Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.
  Eligibility

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
Criteria

Inclusion Criteria:

  • Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies.
  • Adults ? 18 years of age
  • Chronic HBV infection, known to be HbsAg positive ? 6 months
  • Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study
  • Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment
  • HIV negative
  • Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
  • No need for excluded medications
  • Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal)

Exclusion Criteria

  • HIV infection
  • Active Hepatitis C co-infection
  • Concurrent systemic antiviral treatment
  • Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443
  • 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>10.0 times the upper limit of normal
  • ALT>10.0 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 investigational drug not approved by Medical Monitor
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00037622     History of Changes
Other Study ID Numbers: ACH443-901
First Submitted: May 17, 2002
First Posted: May 20, 2002
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by Achillion Pharmaceuticals:
E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
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