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NCT00088504 · ClinicalTrials.gov registry record · Phase 2
Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
A Phase 2 study of Hepatitis C and Hepatitis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT00088504 is a Phase 2 study of Hepatitis C and Hepatitis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 315 participants, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT00088504, a Phase 2 study of Hepatitis C and Hepatitis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is designed to test whether or not the addition of merimepodib (MMPD) to the standard therapy of pegylated interferon and ribavirin will result in a positive treatment response for people who have not previously responded to this therapy. Approximately 315 subjects will be enrolled in this research study at approximately 55 clinical sites in the United States. There will be three study groups. Everyone in the study will receive Pegasys® (pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each dose level being tested. The third group will take a placebo instead of MMPD, with the Pegasys® and Copegus®. After the first 24 weeks of treatment, blood tests will be done to see if subjects are responding to treatment. If they are responding, they will continue receiving study treatment in the study for another 24 weeks. If they are not responding, they will stop study treatment. Everyone who is responding will be monitored for 24 weeks after the last dose of medication, to see how long the response lasts. Evaluations will be performed during the study to look at the safety of the Pegasys®/Copegus® and MMPD or placebo combination, and to see how the combination is working by measuring Hepatitis C Virus in the blood. At some of the clinical sites performing the study, some subjects may also participate in additional testing to look at the metabolism of the drugs, or to look at the immune response to Hepatitis C virus infection and treatment.
Conditions Studied
Interventions
- DRUG Merimepodib
- DRUG PEG-Interferon-alpha 2a (Pegasys®)
- DRUG Ribavirin (Copegus®)
Study Locations (20)
California
- Michael P. DeMicco, M.D. - Anaheim
- Prahalad B. Jajodia, M.D. - Fresno
- F. Fred Poordad, M.D. - Los Angeles
- Ramsey Cheung, M.D. - Palo Alto
- Myron J. Tong, M.D., Ph.D. - Pasadena
- Michael T. Bennett, M.D. - San Diego
- Lisa M. Nyberg, M.D. - San Diego
- Natalie Bzowej, M.D. - San Francisco
Illinois
- Steven L. Flamm, M.D. - Chicago
- Helen Te, M.D. - Chicago
- Gerald J. Mingoletti, M.D. - Oak Forest
Alabama
- Joseph L. Cochran, M.D. - Birmingham
- Suresh Karne, M.D., Ph.D. - Huntsville
Florida
- Eugene R. Schiff, M.D. - Miami
- Jawahar L. Taunk, M.D. - Palm Harbor
Arizona
- Vijayan Balan, M.D. - Phoenix
Colorado
- Marcelo Kugelmas, M.D. - Englewood
Connecticut
- Herbert L. Bonkovsky, M.D. - Farmington
Georgia
- Arnold L. Lentnek, M.D. - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2004-07 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088504
The ClinicalTrials.gov registry entry for NCT00088504 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (83% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Merimepodib is the first listed.
NCT00088504 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT00088504 about?
NCT00088504 is a clinical study titled "Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C". This trial is designed to test whether or not the addition of merimepodib (MMPD) to the standard therapy of pegylated interferon and ribavirin will result in a positive treatment response for people who have not previously responded to this therapy. Approximately 315 subjects will be enrolled in thi...
What is the current status of trial NCT00088504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 315 participants. The study started on 2004-07. Estimated completion is 2006-10.
What conditions does trial NCT00088504 study?
This clinical trial studies the following conditions: Hepatitis C, Hepatitis.
What interventions are being tested in trial NCT00088504?
The interventions under investigation include: Merimepodib (DRUG), PEG-Interferon-alpha 2a (Pegasys®) (DRUG), Ribavirin (Copegus®) (DRUG).
Who is sponsoring clinical trial NCT00088504?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088504 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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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