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NCT00737568 · ClinicalTrials.gov registry record · Phase 3
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT00737568 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 280 participants.
The verdict
NCT00737568, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study Summary
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen. This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.
Interventions
- DRUG FTC/TDF
- DRUG TDF
- DRUG TDF Placebo
- DRUG FTC/TDF Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00737568
The ClinicalTrials.gov registry entry for NCT00737568 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 280 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 4 interventions - of which FTC/TDF is the first listed.
NCT00737568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00737568 about?
NCT00737568 is a clinical study titled "Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine". The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by prev...
What is the current status of trial NCT00737568?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2008-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00737568?
The interventions under investigation include: FTC/TDF (DRUG), TDF (DRUG), TDF Placebo (DRUG), FTC/TDF Placebo (DRUG).
Who is sponsoring clinical trial NCT00737568?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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