Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
A Phase 2b Study of Merimepodib in Combination With Pegylated Interferon Alfa-2a (Pegasys®) and Ribavirin in Subjects With Chronic Hepatitis C Non-Responsive to Prior Therapy With Pegylated Interferon Alfa and Ribavirin
1 other identifier
interventional
315
1 country
67
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 27, 2004
CompletedFirst Posted
Study publicly available on registry
July 28, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 21, 2007
December 1, 2007
July 27, 2004
December 17, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- If you are not sure whether you meet these criteria, please call the clinical study site nearest you, and they can help you figure out if you might be eligible for the study:
- You must have been diagnosed with Hepatitis C.
- You must have been treated with pegylated interferon (brand names are Pegasys® or Peg-Intron®) and ribavirin (brand names Rebetol® or Copegus®), for at least 12 weeks. However, you cannot have received more than one course of this combination therapy.
- You must have been a "non-responder" to this treatment, meaning that the virus levels in your blood were always detectable. If you responded to the treatment and then the virus became detectable again (called a "relapse"), you would not be eligible.
- You must not have used illegal drugs, or have a history of significant alcohol use, within the last year before you start the study.
- Pegasys® and Copegus® are not recommended for people with some illnesses. You should be in good health in general, with no illnesses that would prevent you from using Pegasys® and Copegus®. If you do not know whether you have any illness or conditions that would prevent you from using these medications, the study doctor or nurse will review your medical history with you to determine this.
- If you are a woman who can have children, you must be willing to use two effective methods of birth control during the study and for 6 months after the last dose of the medication. You will have monthly pregnancy tests during this time to make sure you do not become pregnant (This is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
- If you are a male, your female partner must not be pregnant, and you both must be willing to use birth control during the time you are in the study, and for 6 months after the last dose of the medication (This is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Joseph L. Cochran, M.D.
Birmingham, Alabama, 35209, United States
Suresh Karne, M.D., Ph.D.
Huntsville, Alabama, 35801, United States
Vijayan Balan, M.D.
Phoenix, Arizona, 85054, United States
Michael P. DeMicco, M.D.
Anaheim, California, 92801, United States
Prahalad B. Jajodia, M.D.
Fresno, California, 93703, United States
F. Fred Poordad, M.D.
Los Angeles, California, 90095-7054, United States
Ramsey Cheung, M.D.
Palo Alto, California, 94304, United States
Myron J. Tong, M.D., Ph.D.
Pasadena, California, 91105, United States
Michael T. Bennett, M.D.
San Diego, California, 92123, United States
Lisa M. Nyberg, M.D.
San Diego, California, 92154, United States
Natalie Bzowej, M.D.
San Francisco, California, 94115, United States
Marcelo Kugelmas, M.D.
Englewood, Colorado, 80113, United States
Herbert L. Bonkovsky, M.D.
Farmington, Connecticut, 06030, United States
Eugene R. Schiff, M.D.
Miami, Florida, 33136, United States
Jawahar L. Taunk, M.D.
Palm Harbor, Florida, 34684, United States
Arnold L. Lentnek, M.D.
Marietta, Georgia, 30060, United States
Ellen B. Hunter, M.D.
Boise, Idaho, 83702, United States
Steven L. Flamm, M.D.
Chicago, Illinois, 60611, United States
Helen Te, M.D.
Chicago, Illinois, 60637, United States
Gerald J. Mingoletti, M.D.
Oak Forest, Illinois, 60452, United States
Donald R. Graham, M.D.
Springfield, Illinois, 62703, United States
Alvaro G. Koch, M.D.
Lexington, Kentucky, 40536, United States
Shaban Faruqui, M.D.
Baton Rouge, Louisiana, 70808, United States
Robert M. Be, M.D.
Baton Rouge, Louisiana, 70809, United States
Bal Raj Bhandari, M.D.
Monroe, Louisiana, 71201, United States
Luis A. Balart, M.D.
New Orleans, Louisiana, 70115, United States
Robert Perrillo, M.D.
New Orleans, Louisiana, 70121, United States
Michael Epstein, M.D.
Annapolis, Maryland, 21401, United States
Natarajan Ravendhran, M.D.
Baltimore, Maryland, 21229, United States
Mark Sulkowski, M.D.
Baltimore, Maryland, 21287, United States
Milton J. Koch, M.D.
Silver Spring, Maryland, 20901, United States
David N. Schwartz, M.D.
Attleboro, Massachusetts, 02703, United States
Nezam Afdhal, M.D.
Boston, Massachusetts, 02215, United States
Lawton Shick, M.D.
Worcester, Massachusetts, 01655, United States
Stuart C. Gordon, M.D.
Detroit, Michigan, 48202, United States
John B. Gross, M.D.
Rochester, Minnesota, 55905-0002, United States
Jeffrey Rank, M.D.
Saint Paul, Minnesota, 55446, United States
Adrian Di Bisceglie, M.D.
St Louis, Missouri, 63104, United States
William C. Sloan
Florham Park, New Jersey, 07932, United States
Rajendra Prasad Gupta, M.D.
Trenton, New Jersey, 08618, United States
David Eric Bernstein, M.D.
Manhasset, New York, 11030, United States
Ira M. Jacobson, M.D.
New York, New York, 10021, United States
Douglas T. Dieterich, M.D.
New York, New York, 10029, United States
Robert Reindollar, M.D.
Charlotte, North Carolina, 28207, United States
Andrew Muir, M.D.
Durham, North Carolina, 27710, United States
John E. Poulous, M.D.
Fayetteville, North Carolina, 28304, United States
Mark E. Jonas, M.D.
Cincinnati, Ohio, 45219, United States
Harvey A. Tatum, M.D.
Tulsa, Oklahoma, 74104, United States
George Koval, M.D.
Portland, Oregon, 97225, United States
Jill P. Smith, M.D.
Hershey, Pennsylvania, 17033, United States
Victor Araya, M.D.
Philadelphia, Pennsylvania, 19141, United States
Peter J. Molloy, M.D.
Pittsburgh, Pennsylvania, 15224, United States
James Scott Strohecker, M.D.
Columbia, South Carolina, 29203, United States
Lawrence D. Wruble, M.D.
Memphis, Tennessee, 38120, United States
Ronald Pruitt, M.D.
Nashville, Tennessee, 37205, United States
Gary L. Davis, M.D.
Dallas, Texas, 75246, United States
William M. Lee, M.D.
Dallas, Texas, 75390-9016, United States
George G. Burnazian, M.D.
Houston, Texas, 77004, United States
Rise Stribling, M.D.
Houston, Texas, 77030, United States
Eric J. Lawitz, M.D.
San Antonio, Texas, 78215, United States
Daniel Pambianco, M.D.
Charlottesville, Virginia, 22911, United States
Vinod Rustgi, M.D.
Fairfax, Virginia, 22031-5216, United States
Mitchell Shiffman, M.D.
Richmond, Virginia, 23249, United States
Robert A. Wohlman, M.D.
Bellevue, Washington, 98004-3049, United States
Robert L. Carithers, M.D.
Seattle, Washington, 98195, United States
David Winters McEniry, M.D.
Tacoma, Washington, 98405, United States
Michael F. Lyons II, M.D.
Tacoma, Washington, 98405, United States
Related Publications (1)
Rustgi VK, Lee WM, Lawitz E, Gordon SC, Afdhal N, Poordad F, Bonkovsky HL, Bengtsson L, Chandorkar G, Harding M, McNair L, Aalyson M, Alam J, Kauffman R, Gharakhanian S, McHutchison JG; MErimepodib TRiple cOmbination Study Group. Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders. Hepatology. 2009 Dec;50(6):1719-26. doi: 10.1002/hep.23204.
PMID: 19852040DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Kauffman, MD, PhD
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 27, 2004
First Posted
July 28, 2004
Study Start
July 1, 2004
Study Completion
October 1, 2006
Last Updated
December 21, 2007
Record last verified: 2007-12