- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037622
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
August 18, 2009 updated by: Alexion
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
May 17, 2002
First Submitted That Met QC Criteria
May 17, 2002
First Posted (Estimate)
May 20, 2002
Study Record Updates
Last Update Posted (Estimate)
August 19, 2009
Last Update Submitted That Met QC Criteria
August 18, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dexelvucitabine
Other Study ID Numbers
- ACH443-901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on ACH-126, 443 (beta-L-Fd4C)
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AlexionAchillion, a wholly owned subsidiary of AlexionCompletedHepatitis B, ChronicBulgaria, Former Yugoslavia