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NCT00734162 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT00734162 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 106 participants.
The verdict
NCT00734162, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study Summary
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection. The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients \< 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents. This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.
Interventions
- DRUG Placebo
- DRUG Tenofovir disoproxil fumarate (TDF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734162
The ClinicalTrials.gov registry entry for NCT00734162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00734162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00734162 about?
NCT00734162 is a clinical study titled "Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection". The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection. The optimal treatment for adolescents with chronic HBV infection is currently unknown....
What is the current status of trial NCT00734162?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2008-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00734162?
The interventions under investigation include: Placebo (DRUG), Tenofovir disoproxil fumarate (TDF) (DRUG).
Who is sponsoring clinical trial NCT00734162?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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