Hepatitis C Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 315 |
| Est. completion date | October 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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.). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Michael P. DeMicco, M.D. | Anaheim | California |
| United States | Michael Epstein, M.D. | Annapolis | Maryland |
| United States | David N. Schwartz, M.D. | Attleboro | Massachusetts |
| United States | Mark Sulkowski, M.D. | Baltimore | Maryland |
| United States | Natarajan Ravendhran, M.D. | Baltimore | Maryland |
| United States | Robert M. Be, M.D. | Baton Rouge | Louisiana |
| United States | Shaban Faruqui, M.D. | Baton Rouge | Louisiana |
| United States | Robert A. Wohlman, M.D. | Bellevue | Washington |
| United States | Joseph L. Cochran, M.D. | Birmingham | Alabama |
| United States | Ellen B. Hunter, M.D. | Boise | Idaho |
| United States | Nezam Afdhal, M.D. | Boston | Massachusetts |
| United States | Robert Reindollar, M.D. | Charlotte | North Carolina |
| United States | Daniel Pambianco, M.D. | Charlottesville | Virginia |
| United States | Helen Te, M.D. | Chicago | Illinois |
| United States | Steven L. Flamm, M.D. | Chicago | Illinois |
| United States | Mark E. Jonas, M.D. | Cincinnati | Ohio |
| United States | James Scott Strohecker, M.D. | Columbia | South Carolina |
| United States | Gary L. Davis, M.D. | Dallas | Texas |
| United States | William M. Lee, M.D. | Dallas | Texas |
| United States | Stuart C. Gordon, M.D. | Detroit | Michigan |
| United States | Andrew Muir, M.D. | Durham | North Carolina |
| United States | Marcelo Kugelmas, M.D. | Englewood | Colorado |
| United States | Vinod Rustgi, M.D. | Fairfax | Virginia |
| United States | Herbert L. Bonkovsky, M.D. | Farmington | Connecticut |
| United States | John E. Poulous, M.D. | Fayetteville | North Carolina |
| United States | William C. Sloan | Florham Park | New Jersey |
| United States | Prahalad B. Jajodia, M.D. | Fresno | California |
| United States | Jill P. Smith, M.D. | Hershey | Pennsylvania |
| United States | George G. Burnazian, M.D. | Houston | Texas |
| United States | Rise Stribling, M.D. | Houston | Texas |
| United States | Suresh Karne, M.D., Ph.D. | Huntsville | Alabama |
| United States | Alvaro G. Koch, M.D. | Lexington | Kentucky |
| United States | F. Fred Poordad, M.D. | Los Angeles | California |
| United States | David Eric Bernstein, M.D. | Manhasset | New York |
| United States | Arnold L. Lentnek, M.D. | Marietta | Georgia |
| United States | Lawrence D. Wruble, M.D. | Memphis | Tennessee |
| United States | Eugene R. Schiff, M.D. | Miami | Florida |
| United States | Bal Raj Bhandari, M.D. | Monroe | Louisiana |
| United States | Ronald Pruitt, M.D. | Nashville | Tennessee |
| United States | Luis A. Balart, M.D. | New Orleans | Louisiana |
| United States | Robert Perrillo, M.D. | New Orleans | Louisiana |
| United States | Douglas T. Dieterich, M.D. | New York | New York |
| United States | Ira M. Jacobson, M.D. | New York | New York |
| United States | Gerald J. Mingoletti, M.D. | Oak Forest | Illinois |
| United States | Jawahar L. Taunk, M.D. | Palm Harbor | Florida |
| United States | Ramsey Cheung, M.D. | Palo Alto | California |
| United States | Myron J. Tong, M.D., Ph.D. | Pasadena | California |
| United States | Victor Araya, M.D. | Philadelphia | Pennsylvania |
| United States | Vijayan Balan, M.D. | Phoenix | Arizona |
| United States | Peter J. Molloy, M.D. | Pittsburgh | Pennsylvania |
| United States | George Koval, M.D. | Portland | Oregon |
| United States | Mitchell Shiffman, M.D. | Richmond | Virginia |
| United States | John B. Gross, M.D. | Rochester | Minnesota |
| United States | Adrian Di Bisceglie, M.D. | Saint Louis | Missouri |
| United States | Jeffrey Rank, M.D. | Saint Paul | Minnesota |
| United States | Eric J. Lawitz, M.D. | San Antonio | Texas |
| United States | Lisa M. Nyberg, M.D. | San Diego | California |
| United States | Michael T. Bennett, M.D. | San Diego | California |
| United States | Natalie Bzowej, M.D. | San Francisco | California |
| United States | Robert L. Carithers, M.D. | Seattle | Washington |
| United States | Milton J. Koch, M.D. | Silver Spring | Maryland |
| United States | Donald R. Graham, M.D. | Springfield | Illinois |
| United States | David Winters McEniry, M.D. | Tacoma | Washington |
| United States | Michael F. Lyons II, M.D. | Tacoma | Washington |
| United States | Rajendra Prasad Gupta, M.D. | Trenton | New Jersey |
| United States | Harvey A. Tatum, M.D. | Tulsa | Oklahoma |
| United States | Lawton Shick, M.D. | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Vertex Pharmaceuticals Incorporated |
United States,
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