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.)
Information provided by:
First received: May 17, 2002
Last updated: August 18, 2009
Last verified: August 2009
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.
Chronic Hepatitis B
Drug: ACH-126, 443 (beta-L-Fd4C)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
| Estimated Enrollment:
| Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 17, 2002
||August 18, 2009
||United States: Food and Drug Administration
Keywords provided by Achillion Pharmaceuticals:
E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Hepatitis, Viral, Human