NCT00037622

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

May 17, 2002

Last Update Submit

August 18, 2009

Conditions

Chronic Hepatitis B

Keywords

E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion

Interventions

ACH-126, 443 (beta-L-Fd4C)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

dexelvucitabine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Study Completion

May 1, 2003

Last Updated

August 19, 2009

Record last verified: 2009-08