Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00023309 · ClinicalTrials.gov registry record · Phase 2
Lamivudine and Adefovir to Treat Chronic Hepatitis B
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00023309 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 41 participants.
The verdict
NCT00023309, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of those in whom it initially works develop resistance after 1 to 3 years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and improvement in liver disease. However combining two anti-viral agents may be superior to using one alone, similar to the strategy employed for the treatment of AIDS. This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B. Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. They will have a blood test to confirm HBV infection. Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months. Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks for the rest of the treatment period. Patients will be evaluated at the end of 1 year. Patients who have not improved with treatment will stop taking the treatment and will be evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an improvement in their liver injury may continue taking lamivudine and adefovir or adefovir alone for 4 more years, as long as they continue to improve with th
Interventions
- DRUG Lamivudine and adefovir
- DRUG Adefovir alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2001-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023309
The ClinicalTrials.gov registry entry for NCT00023309 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lamivudine and adefovir is the first listed.
NCT00023309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00023309 about?
NCT00023309 is a clinical study titled "Lamivudine and Adefovir to Treat Chronic Hepatitis B". This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of t...
What is the current status of trial NCT00023309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2001-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00023309?
The interventions under investigation include: Lamivudine and adefovir (DRUG), Adefovir alone (DRUG).
Who is sponsoring clinical trial NCT00023309?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.