Back to resultsMerimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
Primary Purpose
Hepatitis C, Hepatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Merimepodib
PEG-Interferon-alpha 2a (Pegasys®)
Ribavirin (Copegus®)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis
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.).
Sites / Locations
- Joseph L. Cochran, M.D.
- Suresh Karne, M.D., Ph.D.
- Vijayan Balan, M.D.
- Michael P. DeMicco, M.D.
- Prahalad B. Jajodia, M.D.
- F. Fred Poordad, M.D.
- Ramsey Cheung, M.D.
- Myron J. Tong, M.D., Ph.D.
- Michael T. Bennett, M.D.
- Lisa M. Nyberg, M.D.
- Natalie Bzowej, M.D.
- Marcelo Kugelmas, M.D.
- Herbert L. Bonkovsky, M.D.
- Eugene R. Schiff, M.D.
- Jawahar L. Taunk, M.D.
- Arnold L. Lentnek, M.D.
- Ellen B. Hunter, M.D.
- Steven L. Flamm, M.D.
- Helen Te, M.D.
- Gerald J. Mingoletti, M.D.
- Donald R. Graham, M.D.
- Alvaro G. Koch, M.D.
- Shaban Faruqui, M.D.
- Robert M. Be, M.D.
- Bal Raj Bhandari, M.D.
- Luis A. Balart, M.D.
- Robert Perrillo, M.D.
- Michael Epstein, M.D.
- Natarajan Ravendhran, M.D.
- Mark Sulkowski, M.D.
- Milton J. Koch, M.D.
- David N. Schwartz, M.D.
- Nezam Afdhal, M.D.
- Lawton Shick, M.D.
- Stuart C. Gordon, M.D.
- John B. Gross, M.D.
- Jeffrey Rank, M.D.
- Adrian Di Bisceglie, M.D.
- William C. Sloan
- Rajendra Prasad Gupta, M.D.
- David Eric Bernstein, M.D.
- Ira M. Jacobson, M.D.
- Douglas T. Dieterich, M.D.
- Robert Reindollar, M.D.
- Andrew Muir, M.D.
- John E. Poulous, M.D.
- Mark E. Jonas, M.D.
- Harvey A. Tatum, M.D.
- George Koval, M.D.
- Jill P. Smith, M.D.
- Victor Araya, M.D.
- Peter J. Molloy, M.D.
- James Scott Strohecker, M.D.
- Lawrence D. Wruble, M.D.
- Ronald Pruitt, M.D.
- Gary L. Davis, M.D.
- William M. Lee, M.D.
- George G. Burnazian, M.D.
- Rise Stribling, M.D.
- Eric J. Lawitz, M.D.
- Daniel Pambianco, M.D.
- Vinod Rustgi, M.D.
- Mitchell Shiffman, M.D.
- Robert A. Wohlman, M.D.
- Robert L. Carithers, M.D.
- David Winters McEniry, M.D.
- Michael F. Lyons II, M.D.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00088504
First Posted
July 27, 2004
Last Updated
December 17, 2007
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00088504
Brief Title
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
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis
Keywords
Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
315 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Merimepodib
Intervention Type
Drug
Intervention Name(s)
PEG-Interferon-alpha 2a (Pegasys®)
Intervention Type
Drug
Intervention Name(s)
Ribavirin (Copegus®)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kauffman, MD, PhD
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Joseph L. Cochran, M.D.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Suresh Karne, M.D., Ph.D.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Vijayan Balan, M.D.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Michael P. DeMicco, M.D.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Prahalad B. Jajodia, M.D.
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
F. Fred Poordad, M.D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7054
Country
United States
Facility Name
Ramsey Cheung, M.D.
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Myron J. Tong, M.D., Ph.D.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Michael T. Bennett, M.D.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lisa M. Nyberg, M.D.
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
Natalie Bzowej, M.D.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Marcelo Kugelmas, M.D.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Herbert L. Bonkovsky, M.D.
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Eugene R. Schiff, M.D.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Jawahar L. Taunk, M.D.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Arnold L. Lentnek, M.D.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ellen B. Hunter, M.D.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Steven L. Flamm, M.D.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Helen Te, M.D.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Gerald J. Mingoletti, M.D.
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Donald R. Graham, M.D.
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Alvaro G. Koch, M.D.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Shaban Faruqui, M.D.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Robert M. Be, M.D.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Bal Raj Bhandari, M.D.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Luis A. Balart, M.D.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Robert Perrillo, M.D.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Michael Epstein, M.D.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Natarajan Ravendhran, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Mark Sulkowski, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Milton J. Koch, M.D.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
David N. Schwartz, M.D.
City
Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02703
Country
United States
Facility Name
Nezam Afdhal, M.D.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lawton Shick, M.D.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Stuart C. Gordon, M.D.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
John B. Gross, M.D.
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0002
Country
United States
Facility Name
Jeffrey Rank, M.D.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Adrian Di Bisceglie, M.D.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
William C. Sloan
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Rajendra Prasad Gupta, M.D.
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
David Eric Bernstein, M.D.
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Ira M. Jacobson, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Douglas T. Dieterich, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Robert Reindollar, M.D.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Andrew Muir, M.D.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
John E. Poulous, M.D.
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Mark E. Jonas, M.D.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Harvey A. Tatum, M.D.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
George Koval, M.D.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Jill P. Smith, M.D.
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Victor Araya, M.D.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Peter J. Molloy, M.D.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
James Scott Strohecker, M.D.
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Lawrence D. Wruble, M.D.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Ronald Pruitt, M.D.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Gary L. Davis, M.D.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
William M. Lee, M.D.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
George G. Burnazian, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Rise Stribling, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Eric J. Lawitz, M.D.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Daniel Pambianco, M.D.
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Vinod Rustgi, M.D.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031-5216
Country
United States
Facility Name
Mitchell Shiffman, M.D.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Robert A. Wohlman, M.D.
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004-3049
Country
United States
Facility Name
Robert L. Carithers, M.D.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
David Winters McEniry, M.D.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Michael F. Lyons II, M.D.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19852040
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.
Results Reference
derived
Learn more about this trial
Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
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