Status:
COMPLETED
Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Hepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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.).
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00088504
Start Date
July 1 2004
End Date
October 1 2006
Last Update
December 21 2007
Active Locations (67)
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1
Joseph L. Cochran, M.D.
Birmingham, Alabama, United States, 35209
2
Suresh Karne, M.D., Ph.D.
Huntsville, Alabama, United States, 35801
3
Vijayan Balan, M.D.
Phoenix, Arizona, United States, 85054
4
Michael P. DeMicco, M.D.
Anaheim, California, United States, 92801