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Hepatitis CPhase 2NCT00088504

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

A Phase 2 study testing Merimepodib, PEG-Interferon-alpha 2a (Pegasys®) and Ribavirin (Copegus®) in people with Hepatitis C and Hepatitis, run by Vertex Pharmaceuticals Incorporated at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Hepatitis
What is being tested?
Merimepodib, PEG-Interferon-alpha 2a (Pegasys®) and Ribavirin (Copegus®)
How many people
315 participants
Where
67 sitesUnited States
Study dates
Jul 2004to Oct 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.).

Who cannot join

None listed.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Michael P. DeMicco, M.D.

    Anaheim, California, 92801

  • Michael Epstein, M.D.

    Annapolis, Maryland, 21401

  • David N. Schwartz, M.D.

    Attleboro, Massachusetts, 02703

  • Natarajan Ravendhran, M.D.

    Baltimore, Maryland, 21229

  • Mark Sulkowski, M.D.

    Baltimore, Maryland, 21287

  • Shaban Faruqui, M.D.

    Baton Rouge, Louisiana, 70808

  • Robert M. Be, M.D.

    Baton Rouge, Louisiana, 70809

  • Robert A. Wohlman, M.D.

    Bellevue, Washington, 98004-3049

  • Joseph L. Cochran, M.D.

    Birmingham, Alabama, 35209

  • Ellen B. Hunter, M.D.

    Boise, Idaho, 83702

  • Nezam Afdhal, M.D.

    Boston, Massachusetts, 02215

  • Robert Reindollar, M.D.

    Charlotte, North Carolina, 28207

  • Daniel Pambianco, M.D.

    Charlottesville, Virginia, 22911

  • Steven L. Flamm, M.D.

    Chicago, Illinois, 60611

  • Helen Te, M.D.

    Chicago, Illinois, 60637

  • Mark E. Jonas, M.D.

    Cincinnati, Ohio, 45219

  • James Scott Strohecker, M.D.

    Columbia, South Carolina, 29203

  • Gary L. Davis, M.D.

    Dallas, Texas, 75246

  • William M. Lee, M.D.

    Dallas, Texas, 75390-9016

  • Stuart C. Gordon, M.D.

    Detroit, Michigan, 48202

  • Andrew Muir, M.D.

    Durham, North Carolina, 27710

  • Marcelo Kugelmas, M.D.

    Englewood, Colorado, 80113

  • Vinod Rustgi, M.D.

    Fairfax, Virginia, 22031-5216

  • Herbert L. Bonkovsky, M.D.

    Farmington, Connecticut, 06030

  • John E. Poulous, M.D.

    Fayetteville, North Carolina, 28304

  • William C. Sloan

    Florham Park, New Jersey, 07932

  • Prahalad B. Jajodia, M.D.

    Fresno, California, 93703

  • Jill P. Smith, M.D.

    Hershey, Pennsylvania, 17033

  • George G. Burnazian, M.D.

    Houston, Texas, 77004

  • Rise Stribling, M.D.

    Houston, Texas, 77030

  • Suresh Karne, M.D., Ph.D.

    Huntsville, Alabama, 35801

  • Alvaro G. Koch, M.D.

    Lexington, Kentucky, 40536

  • F. Fred Poordad, M.D.

    Los Angeles, California, 90095-7054

  • David Eric Bernstein, M.D.

    Manhasset, New York, 11030

  • Arnold L. Lentnek, M.D.

    Marietta, Georgia, 30060

  • Lawrence D. Wruble, M.D.

    Memphis, Tennessee, 38120

  • Eugene R. Schiff, M.D.

    Miami, Florida, 33136

  • Bal Raj Bhandari, M.D.

    Monroe, Louisiana, 71201

  • Ronald Pruitt, M.D.

    Nashville, Tennessee, 37205

  • Luis A. Balart, M.D.

    New Orleans, Louisiana, 70115

  • Robert Perrillo, M.D.

    New Orleans, Louisiana, 70121

  • Ira M. Jacobson, M.D.

    New York, New York, 10021

  • Douglas T. Dieterich, M.D.

    New York, New York, 10029

  • Gerald J. Mingoletti, M.D.

    Oak Forest, Illinois, 60452

  • Jawahar L. Taunk, M.D.

    Palm Harbor, Florida, 34684

  • Ramsey Cheung, M.D.

    Palo Alto, California, 94304

  • Myron J. Tong, M.D., Ph.D.

    Pasadena, California, 91105

  • Victor Araya, M.D.

    Philadelphia, Pennsylvania, 19141

  • Vijayan Balan, M.D.

    Phoenix, Arizona, 85054

  • Peter J. Molloy, M.D.

    Pittsburgh, Pennsylvania, 15224

  • George Koval, M.D.

    Portland, Oregon, 97225

  • Mitchell Shiffman, M.D.

    Richmond, Virginia, 23249

  • John B. Gross, M.D.

    Rochester, Minnesota, 55905-0002

  • Jeffrey Rank, M.D.

    Saint Paul, Minnesota, 55446

  • Eric J. Lawitz, M.D.

    San Antonio, Texas, 78215

  • Michael T. Bennett, M.D.

    San Diego, California, 92123

  • Lisa M. Nyberg, M.D.

    San Diego, California, 92154

  • Natalie Bzowej, M.D.

    San Francisco, California, 94115

  • Robert L. Carithers, M.D.

    Seattle, Washington, 98195

  • Milton J. Koch, M.D.

    Silver Spring, Maryland, 20901

  • Donald R. Graham, M.D.

    Springfield, Illinois, 62703

  • Adrian Di Bisceglie, M.D.

    St Louis, Missouri, 63104

  • David Winters McEniry, M.D.

    Tacoma, Washington, 98405

  • Michael F. Lyons II, M.D.

    Tacoma, Washington, 98405

  • Rajendra Prasad Gupta, M.D.

    Trenton, New Jersey, 08618

  • Harvey A. Tatum, M.D.

    Tulsa, Oklahoma, 74104

  • Lawton Shick, M.D.

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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.

Read more

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.

Being tested
Merimepodib, PEG-Interferon-alpha 2a (Pegasys®), Ribavirin (Copegus®)
Keywords
Hepatitis
Medical subject headings
Hepatitis C, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MerimepodibDrug

  • PEG-Interferon-alpha 2a (Pegasys®)Drug

  • Ribavirin (Copegus®)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2004 (estimated)
  2. Study startJul 2004
  3. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
315 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088504
Sponsor's protocol ID
VX03-497-205
Status last verified
Dec 2007
First submitted
27 Jul 2004
Last updated
21 Dec 2007
Results posted
No

Publications

  • 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.

    PubMed 19852040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Merimepodib, PEG-Interferon-alpha 2a (Pegasys®) and Ribavirin (Copegus®) in people with Hepatitis C and Hepatitis, run by Vertex Pharmaceuticals Incorporated at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00088504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.

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