Clinical trial NCT00088504: Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Hepatitis
Keywords: Hepatitis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2004-07-28
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Joseph L. Cochran, M.D.
state: Alabama
city: Huntsville
country: United States
facility: Suresh Karne, M.D., Ph.D.
state: Alabama
city: Phoenix
country: United States
facility: Vijayan Balan, M.D.
state: Arizona
city: Anaheim
country: United States
facility: Michael P. DeMicco, M.D.
state: California
city: Fresno
country: United States
facility: Prahalad B. Jajodia, M.D.
state: California
city: Los Angeles
country: United States
facility: F. Fred Poordad, M.D.
state: California
city: Palo Alto
country: United States
facility: Ramsey Cheung, M.D.
state: California
city: Pasadena
country: United States
facility: Myron J. Tong, M.D., Ph.D.
state: California
city: San Diego
country: United States
facility: Michael T. Bennett, M.D.
state: California
city: San Diego
country: United States
facility: Lisa M. Nyberg, M.D.
state: California
city: San Francisco
country: United States
facility: Natalie Bzowej, M.D.
state: California
city: Englewood
country: United States
facility: Marcelo Kugelmas, M.D.
state: Colorado
city: Farmington
country: United States
facility: Herbert L. Bonkovsky, M.D.
state: Connecticut
city: Miami
country: United States
facility: Eugene R. Schiff, M.D.
state: Florida
city: Palm Harbor
country: United States
facility: Jawahar L. Taunk, M.D.
state: Florida
city: Marietta
country: United States
facility: Arnold L. Lentnek, M.D.
state: Georgia
city: Boise
country: United States
facility: Ellen B. Hunter, M.D.
state: Idaho
city: Chicago
country: United States
facility: Steven L. Flamm, M.D.
state: Illinois
city: Chicago
country: United States
facility: Helen Te, M.D.
state: Illinois
city: Oak Forest
country: United States
facility: Gerald J. Mingoletti, M.D.
state: Illinois
city: Springfield
country: United States
facility: Donald R. Graham, M.D.
state: Illinois
city: Lexington
country: United States
facility: Alvaro G. Koch, M.D.
state: Kentucky
city: Baton Rouge
country: United States
facility: Shaban Faruqui, M.D.
state: Louisiana
city: Baton Rouge
country: United States
facility: Robert M. Be, M.D.
state: Louisiana
city: Monroe
country: United States
facility: Bal Raj Bhandari, M.D.
state: Louisiana
city: New Orleans
country: United States
facility: Luis A. Balart, M.D.
state: Louisiana
city: New Orleans
country: United States
facility: Robert Perrillo, M.D.
state: Louisiana
city: Annapolis
country: United States
facility: Michael Epstein, M.D.
state: Maryland
city: Baltimore
country: United States
facility: Natarajan Ravendhran, M.D.
state: Maryland
city: Baltimore
country: United States
facility: Mark Sulkowski, M.D.
state: Maryland
city: Silver Spring
country: United States
facility: Milton J. Koch, M.D.
state: Maryland
city: Attleboro
country: United States
facility: David N. Schwartz, M.D.
state: Massachusetts
city: Boston
country: United States
facility: Nezam Afdhal, M.D.
state: Massachusetts
city: Worcester
country: United States
facility: Lawton Shick, M.D.
state: Massachusetts
city: Detroit
country: United States
facility: Stuart C. Gordon, M.D.
state: Michigan
city: Rochester
country: United States
facility: John B. Gross, M.D.
state: Minnesota
city: Saint Paul
country: United States
facility: Jeffrey Rank, M.D.
state: Minnesota
city: Saint Louis
country: United States
facility: Adrian Di Bisceglie, M.D.
state: Missouri
city: Florham Park
country: United States
facility: William C. Sloan
state: New Jersey
city: Trenton
country: United States
facility: Rajendra Prasad Gupta, M.D.
state: New Jersey
city: Manhasset
country: United States
facility: David Eric Bernstein, M.D.
state: New York
city: New York
country: United States
facility: Ira M. Jacobson, M.D.
state: New York
city: New York
country: United States
facility: Douglas T. Dieterich, M.D.
state: New York
city: Charlotte
country: United States
facility: Robert Reindollar, M.D.
state: North Carolina
city: Durham
country: United States
facility: Andrew Muir, M.D.
state: North Carolina
city: Fayetteville
country: United States
facility: John E. Poulous, M.D.
state: North Carolina
city: Cincinnati
country: United States
facility: Mark E. Jonas, M.D.
state: Ohio
city: Tulsa
country: United States
facility: Harvey A. Tatum, M.D.
state: Oklahoma
city: Portland
country: United States
facility: George Koval, M.D.
state: Oregon
city: Hershey
country: United States
facility: Jill P. Smith, M.D.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Victor Araya, M.D.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Peter J. Molloy, M.D.
state: Pennsylvania
city: Columbia
country: United States
facility: James Scott Strohecker, M.D.
state: South Carolina
city: Memphis
country: United States
facility: Lawrence D. Wruble, M.D.
state: Tennessee
city: Nashville
country: United States
facility: Ronald Pruitt, M.D.
state: Tennessee
city: Dallas
country: United States
facility: Gary L. Davis, M.D.
state: Texas
city: Dallas
country: United States
facility: William M. Lee, M.D.
state: Texas
city: Houston
country: United States
facility: George G. Burnazian, M.D.
state: Texas
city: Houston
country: United States
facility: Rise Stribling, M.D.
state: Texas
city: San Antonio
country: United States
facility: Eric J. Lawitz, M.D.
state: Texas
city: Charlottesville
country: United States
facility: Daniel Pambianco, M.D.
state: Virginia
city: Fairfax
country: United States
facility: Vinod Rustgi, M.D.
state: Virginia
city: Richmond
country: United States
facility: Mitchell Shiffman, M.D.
state: Virginia
city: Bellevue
country: United States
facility: Robert A. Wohlman, M.D.
state: Washington
city: Seattle
country: United States
facility: Robert L. Carithers, M.D.
state: Washington
city: Tacoma
country: United States
facility: David Winters McEniry, M.D.
state: Washington
city: Tacoma
country: United States
facility: Michael F. Lyons II, M.D.
state: Washington
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Robert Kauffman, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.