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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
May 17, 2002
May 20, 2002
August 19, 2009
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Complete list of historical versions of study NCT00037622 on ClinicalTrials.gov Archive Site
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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.
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
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.
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.
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: ACH-126, 443 (beta-L-Fd4C)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
May 2003
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00037622
ACH443-901
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Achillion Pharmaceuticals
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Achillion Pharmaceuticals
August 2009

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