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NCT00230477 · ClinicalTrials.gov registry record · Phase 4
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
A Phase 4 study of Hepatitis B, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00230477 is a Phase 4 study of Hepatitis B that has completed, run by University of Washington. The registered enrollment target is 19 participants, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00230477, a Phase 4 study of Hepatitis B, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B. The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.
Conditions Studied
Interventions
- DRUG Hepsera
- DRUG Hepsera and lamivudine
Study Locations (1)
Washington
- Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2003-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00230477
The ClinicalTrials.gov registry entry for NCT00230477 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Hepsera is the first listed.
NCT00230477 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT00230477 about?
NCT00230477 is a clinical study titled "Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT". This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B. The p...
What is the current status of trial NCT00230477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2003-04. Estimated completion is 2007-08.
What conditions does trial NCT00230477 study?
This clinical trial studies the following conditions: Hepatitis B.
What interventions are being tested in trial NCT00230477?
The interventions under investigation include: Hepsera (DRUG), Hepsera and lamivudine (DRUG).
Who is sponsoring clinical trial NCT00230477?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00230477 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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