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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
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 July 22, 2014
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections