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Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult Patients

NCT01267162 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2016-03-16

No results posted yet for this study

Summary

This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. The primary objective of this study is to evaluate the long-term antiviral efficacy of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate the safety and tolerability of TDF including the biochemical and virological responses to TDF, the incidence of drug resistance mutations in these patients The duration of treatment in this study is total of three Years (144 weeks) on TDF.

Conditions

Sponsors & Collaborators

  • Medical Procare PLLC

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01267162 on ClinicalTrials.gov