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:
Achillion Pharmaceuticals
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00037622
First received: May 17, 2002
Last updated: August 18, 2009
Last verified: August 2009
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
Related Info 
No publications provided
| ClinicalTrials.gov Identifier: | NCT00037622 History of Changes |
| Other Study ID Numbers: | ACH443-901 |
| Study First Received: | May 17, 2002 |
| Last Updated: | August 18, 2009 |
| Health Authority: | 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:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic 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 |
ClinicalTrials.gov processed this record on June 18, 2013