Merimepodib (MMPD): Clinical trial for non-responders now
recruiting patients


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

This study is currently recruiting patients.

Sponsored by: Vertex Pharmaceuticals
Information provided by: Vertex Pharmaceuticals


Purpose

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.




Condition Treatment or Intervention Phase
Hepatitis C
Hepatitis
Drug: Merimepodib
Drug: PEG-Interferon-alpha 2a (Pegasys®)
Drug: Ribavirin (Copegus®)
Phase II


MedlinePlus related topics: Hepatitis; Hepatitis C


Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control,
Parallel
Assignment, Safety/Efficacy 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

Further Study Details: Expected Total Enrollment: 315



Study start: July 2004


Eligibility

Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible
for
Study: Both


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.).



Location and Contact Information


California
F. Fred Poordad, M.D., Los Angeles, California, 90095-7054,
United
States; Recruiting Sandy Leong 310-423-2641 leongs@...


Myron J. Tong, M.D., Ph.D., Pasadena, California, 91105,
United
States; Recruiting Ruth Co 626-397-5825 ruthco@...


Colorado
Marcelo Kugelmas, M.D., Englewood, Colorado, 80113, United
States;
Recruiting Lu Atronica, RN 303-788-8888 Ext. 139


Florida
Eugene R. Schiff, M.D., Miami, Florida, 33136, United States;
Recruiting Amy Siebert 305-243-4649 asiebert@...


Illinois
Donald R. Graham, M.D., Springfield, Illinois, 62703, United
States;
Recruiting Vickie Molnar 217-527-4745
research@...


Louisiana
Shaban Faruqui, M.D., Baton Rouge, Louisiana, 70808, United
States;
Recruiting Naomy Reed 225-757-1084 naomy@...


Luis A. Balart, M.D., New Orleans, Louisiana, 70115, United
States;
Recruiting Angela Piacun 504-891-8311 apiacu@...


Robert Perrillo, M.D., New Orleans, Louisiana, 70121, United
States;
Recruiting Cheryl Denham 504-842-4895 cdenham@...


Bal Raj Bhandari, M.D., Monroe, Louisiana, 71201, United
States;
Recruiting Jereta Lawrence 318-325-2634 jeretajtlaw@...


Maryland
Michael Epstein, M.D., Annapolis, Maryland, 21401, United
States;
Recruiting Kim Nordstrom 410-266-8999 Ext. 444
kim.nordstrom@...


Massachusetts
David N. Schwartz, M.D., Attleboro, Massachusetts, 02703,
United
States; Recruiting Margo Arel 508-954-2791
margo.arel@...


New Jersey
Rajendra Prasad Gupta, M.D., Trenton, New Jersey, 08618,
United
States; Recruiting Anna Samczuk 609-530-1181
anna.samczuk@...


New York
David Eric Bernstein, M.D., Manhasset, New York, 11030, United
States; Recruiting Maly Tiev 516-562-1364 mchhua@...


Douglas T. Dieterich, M.D., New York, New York, 10029, United
States; Recruiting Patricia Mastrangelo 212-241-8903
Patricia.Mastrangelo@...


North Carolina
Robert Reindollar, M.D., Charlotte, North Carolina, 28207,
United
States; Recruiting Martha Hudson 704-378-4371 Ext. 109
mhudson@...


Andrew Muir, M.D., Durham, North Carolina, 27710, United
States;
Recruiting Alethia Karkanis 919-684-8992 karka001@...


Pennsylvania
Victor Araya, M.D., Philadelphia, Pennsylvania, 19141, United
States; Recruiting Stacey Carmody 215-456-7534 misracc@...


Tennessee
Ronald Pruitt, M.D., Nashville, Tennessee, 37205, United
States;
Recruiting Valerie Wall 615-383-1727
vwall@...


Texas
Eric J. Lawitz, M.D., San Antonio, Texas, 78215, United
States;
Recruiting Michael France 210-253-3426


William M. Lee, M.D., Dallas, Texas, 75390-9016, United
States;
Recruiting Rivka Elbein 214-648-4801
rivka.elbein@...


Virginia
Vinod Rustgi, M.D., Fairfax, Virginia, 22031-5216, United
States;
Recruiting Fatema Hassani 703-698-9254 Ext. 21


Daniel Pambianco, M.D., Charlottesville, Virginia, 22911,
United
States; Recruiting Claudia Wisman 434-817-2442
poodyw@...


Washington
Michael F. Lyons II, M.D., Tacoma, Washington, 98405, United
States;
Recruiting Jackie Christel 253-284-5187 jchristel@...


David Winters McEniry, M.D., Tacoma, Washington, 98405, United
States; Recruiting Catherine Sanders 253-396-5329
csanders@...


Robert A. Wohlman, M.D., Bellevue, Washington, 98004-3049,
United
States; Recruiting Karen Schwartz 425-452-8547
karen@...


More Information

http://www.metrotrial.com

Study ID Numbers: VX03-497-205
Record last reviewed: November 2004
Record first received: July 27, 2004
ClinicalTrials.gov Identifier: NCT00088504
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-12-01








Sandra Tara Balduf (Ane)

Frontline Hepatitis Awareness

Support for patients and educational materials

http://frontline-hepatitis-awareness.com

1-866-Hep-GoGo 866-437-4646




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