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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. - Article


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Agalsidase Beta

Fabrazyme


Clinical Trial: Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with chronic Hepatitis B infection.

This study is no longer recruiting patients.

Sponsored by: Achillion Pharmaceuticals
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 Treatment or Intervention
Chronic Hepatitis B
 Drug: ACH-126, 443 (beta-L-Fd4C)

MedlinePlus related topics:  Hepatitis;   Hepatitis B

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  100

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

More Information

http://www.achillion.com

Study ID Numbers:  ACH443-901
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  May 17, 2002
ClinicalTrials.gov Identifier:  NCT00037622
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 15, 2008



Page Updated: June 1, 2005
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