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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.

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: NCT00037622
Recruitment Status : Terminated (Safety concerns from other studies.)
First Posted : May 20, 2002
Last Update Posted : August 19, 2009
Information provided by:
Achillion Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ACH-126, 443 (beta-L-Fd4C) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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
Actual Study Completion Date : May 2003

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

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

Additional Information:
Layout table for additonal information Identifier: NCT00037622    
Other Study ID Numbers: ACH443-901
First Posted: May 20, 2002    Key Record Dates
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:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents