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

December 17, 2007 updated by: Vertex Pharmaceuticals Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Investigators

  • Study Director: Robert Kauffman, MD, PhD, Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

July 27, 2004

First Submitted That Met QC Criteria

July 27, 2004

First Posted (Estimate)

July 28, 2004

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX03-497-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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