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NCT00307489 · ClinicalTrials.gov registry record · Phase 2
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT00307489 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 106 participants.
The verdict
NCT00307489, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid \[HBV DNA\]). Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA \< 400 copies/mL). Alternatively, subjects with confirmed HBV DNA \< 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.
Interventions
- DRUG tenofovir DF
- DRUG emtricitabine /tenofovir DF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00307489
The ClinicalTrials.gov registry entry for NCT00307489 describes a study currently listed as completed, categorized as Phase 2. 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 tenofovir DF is the first listed.
NCT00307489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00307489 about?
NCT00307489 is a clinical study titled "Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil". This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who...
What is the current status of trial NCT00307489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2006-03. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00307489?
The interventions under investigation include: tenofovir DF (DRUG), emtricitabine /tenofovir DF (DRUG).
Who is sponsoring clinical trial NCT00307489?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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