Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection. - Tabular View

Tracking Information
First Received Date ^ICMJE	May 17, 2002
Last Updated Date	August 18, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
Official Title ^ICMJE	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
Brief Summary	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.
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 Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: ACH-126, 443 (beta-L-Fd4C)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	100
Completion Date	May 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00037622
Responsible Party
Study ID Numbers ^ICMJE	ACH443-901
Study Sponsor ^ICMJE	Achillion Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Achillion Pharmaceuticals
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP