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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: Completed Phase 4 study of Hepatitis B, sponsored by University of Washington.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00230477 record still lists
NCT00230477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00230477's enrollment target sits among peer trials
19 28th of 32 higher than 5 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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