Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088504
Recruitment Status : Completed
First Posted : July 28, 2004
Last Update Posted : December 21, 2007
Information provided by:
Vertex Pharmaceuticals Incorporated

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis Drug: Merimepodib Drug: PEG-Interferon-alpha 2a (Pegasys®) Drug: Ribavirin (Copegus®) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The following is a summary of the inclusion and exclusion criteria for the Merimepodib Triple Combination (METRO) trial. There are also additional criteria, which will be reviewed with you by the staff at the clinical study site, to make sure you are eligible for the study. Some of the criteria are dependent on the results of blood tests and other tests that will be done at the clinical site.

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088504

  Hide Study Locations
United States, Alabama
Joseph L. Cochran, M.D.
Birmingham, Alabama, United States, 35209
Suresh Karne, M.D., Ph.D.
Huntsville, Alabama, United States, 35801
United States, Arizona
Vijayan Balan, M.D.
Phoenix, Arizona, United States, 85054
United States, California
Michael P. DeMicco, M.D.
Anaheim, California, United States, 92801
Prahalad B. Jajodia, M.D.
Fresno, California, United States, 93703
F. Fred Poordad, M.D.
Los Angeles, California, United States, 90095-7054
Ramsey Cheung, M.D.
Palo Alto, California, United States, 94304
Myron J. Tong, M.D., Ph.D.
Pasadena, California, United States, 91105
Michael T. Bennett, M.D.
San Diego, California, United States, 92123
Lisa M. Nyberg, M.D.
San Diego, California, United States, 92154
Natalie Bzowej, M.D.
San Francisco, California, United States, 94115
United States, Colorado
Marcelo Kugelmas, M.D.
Englewood, Colorado, United States, 80113
United States, Connecticut
Herbert L. Bonkovsky, M.D.
Farmington, Connecticut, United States, 06030
United States, Florida
Eugene R. Schiff, M.D.
Miami, Florida, United States, 33136
Jawahar L. Taunk, M.D.
Palm Harbor, Florida, United States, 34684
United States, Georgia
Arnold L. Lentnek, M.D.
Marietta, Georgia, United States, 30060
United States, Idaho
Ellen B. Hunter, M.D.
Boise, Idaho, United States, 83702
United States, Illinois
Steven L. Flamm, M.D.
Chicago, Illinois, United States, 60611
Helen Te, M.D.
Chicago, Illinois, United States, 60637
Gerald J. Mingoletti, M.D.
Oak Forest, Illinois, United States, 60452
Donald R. Graham, M.D.
Springfield, Illinois, United States, 62703
United States, Kentucky
Alvaro G. Koch, M.D.
Lexington, Kentucky, United States, 40536
United States, Louisiana
Shaban Faruqui, M.D.
Baton Rouge, Louisiana, United States, 70808
Robert M. Be, M.D.
Baton Rouge, Louisiana, United States, 70809
Bal Raj Bhandari, M.D.
Monroe, Louisiana, United States, 71201
Luis A. Balart, M.D.
New Orleans, Louisiana, United States, 70115
Robert Perrillo, M.D.
New Orleans, Louisiana, United States, 70121
United States, Maryland
Michael Epstein, M.D.
Annapolis, Maryland, United States, 21401
Natarajan Ravendhran, M.D.
Baltimore, Maryland, United States, 21229
Mark Sulkowski, M.D.
Baltimore, Maryland, United States, 21287
Milton J. Koch, M.D.
Silver Spring, Maryland, United States, 20901
United States, Massachusetts
David N. Schwartz, M.D.
Attleboro, Massachusetts, United States, 02703
Nezam Afdhal, M.D.
Boston, Massachusetts, United States, 02215
Lawton Shick, M.D.
Worcester, Massachusetts, United States, 01655
United States, Michigan
Stuart C. Gordon, M.D.
Detroit, Michigan, United States, 48202
United States, Minnesota
John B. Gross, M.D.
Rochester, Minnesota, United States, 55905-0002
Jeffrey Rank, M.D.
Saint Paul, Minnesota, United States, 55446
United States, Missouri
Adrian Di Bisceglie, M.D.
Saint Louis, Missouri, United States, 63104
United States, New Jersey
William C. Sloan
Florham Park, New Jersey, United States, 07932
Rajendra Prasad Gupta, M.D.
Trenton, New Jersey, United States, 08618
United States, New York
David Eric Bernstein, M.D.
Manhasset, New York, United States, 11030
Ira M. Jacobson, M.D.
New York, New York, United States, 10021
Douglas T. Dieterich, M.D.
New York, New York, United States, 10029
United States, North Carolina
Robert Reindollar, M.D.
Charlotte, North Carolina, United States, 28207
Andrew Muir, M.D.
Durham, North Carolina, United States, 27710
John E. Poulous, M.D.
Fayetteville, North Carolina, United States, 28304
United States, Ohio
Mark E. Jonas, M.D.
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Harvey A. Tatum, M.D.
Tulsa, Oklahoma, United States, 74104
United States, Oregon
George Koval, M.D.
Portland, Oregon, United States, 97225
United States, Pennsylvania
Jill P. Smith, M.D.
Hershey, Pennsylvania, United States, 17033
Victor Araya, M.D.
Philadelphia, Pennsylvania, United States, 19141
Peter J. Molloy, M.D.
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
James Scott Strohecker, M.D.
Columbia, South Carolina, United States, 29203
United States, Tennessee
Lawrence D. Wruble, M.D.
Memphis, Tennessee, United States, 38120
Ronald Pruitt, M.D.
Nashville, Tennessee, United States, 37205
United States, Texas
Gary L. Davis, M.D.
Dallas, Texas, United States, 75246
William M. Lee, M.D.
Dallas, Texas, United States, 75390-9016
George G. Burnazian, M.D.
Houston, Texas, United States, 77004
Rise Stribling, M.D.
Houston, Texas, United States, 77030
Eric J. Lawitz, M.D.
San Antonio, Texas, United States, 78215
United States, Virginia
Daniel Pambianco, M.D.
Charlottesville, Virginia, United States, 22911
Vinod Rustgi, M.D.
Fairfax, Virginia, United States, 22031-5216
Mitchell Shiffman, M.D.
Richmond, Virginia, United States, 23249
United States, Washington
Robert A. Wohlman, M.D.
Bellevue, Washington, United States, 98004-3049
Robert L. Carithers, M.D.
Seattle, Washington, United States, 98195
David Winters McEniry, M.D.
Tacoma, Washington, United States, 98405
Michael F. Lyons II, M.D.
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated Identifier: NCT00088504     History of Changes
Other Study ID Numbers: VX03-497-205
First Posted: July 28, 2004    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Vertex Pharmaceuticals Incorporated:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs