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Fwd: [NATAP] Two New HCV Studies for Non-responders

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  • claudine intexas
    NATAP - www.natap.org Two New HCV Studies for Non-responders Studies for 2 new drugs for HCV in previous non-responders are beginning. (1) Merimepodib (MMPD)
    Message 1 of 1 , Jan 29, 2005
      NATAP - www.natap.org

      Two New HCV Studies for Non-responders

      Studies for 2 new drugs for HCV in previous non-responders are beginning.

      (1) Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
      A Phase 2b Study of Merimepodib, an IMPDH inhibitor, in Combination with Pegylated Interferon Alfa-2a(Pegasys��) and Ribavirin in Subjects with Chronic Genotype 1 Hepatitis C Non-Responsive to Prior Therapy with Pegylated Interferon Alfa and Ribavirin.

      Comparing treatment of 50mg MMPD vs. 100mg MMPD vs placebo in combination with Pegasys and Ribavirin Subjects: Previously Treated. Genotype 1.

      In NYC Cornell Hospital is a site: Contact: Mary Ahern, ANP maa9041@... 212-746-2115
      Sites around the country are listed below.

      (2) NM283 HCV Ploymerase Inhibitor:
      A Phase 2b Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon plus NM283, in Patients with Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy.

      Comparing the safety,tolerability and antivital activity of NM283, Peg-INF_ 2a/NM283 and Peg-INF_ 2a/ribavirin in patients with genotype-1 chronic hepatitis C who have previously failed to respond to Peg-INF_/ribavirin
      In NYC Cornell Hospital is a site: Contact Mary Ahern, ANP
      maa9041@... '212-746-2115
      At this time I don't have a listing of additional sites but you can ask your local sites if they are conducting the study & I will have site listing next week.

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


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


      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


      Joseph L. Cochran, M.D., Birmingham, Alabama, 35209, United States; Recruiting
      Sarah Ingle 205-271-8000 single@...

      Suresh Karne, M.D., Ph.D., Huntsville, Alabama, 35801, United States; Recruiting
      LuAnne Boggs, LPN 256-533-6603 lboggs@...


      Vijayan Balan, M.D., Phoenix, Arizona, 85054, United States; Recruiting
      Julie Braaten 480-342-1328


      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@...

      Prahalad B. Jajodia, M.D., Fresno, California, 93703, United States; Recruiting
      Vipula Sharma 559-495-6731 universalbiopharmainc@...

      Natalie Bzowej, M.D., San Francisco, California, 94115, United States; Recruiting
      Leslie Taylor 415-600-1109 schmidj@...

      Lisa M. Nyberg, M.D., San Diego, California, 92154, United States; Recruiting
      Karen Cloutman 619-662-5410 karen.a.cloutman@...

      Michael P. DeMicco, M.D., Anaheim, California, 92801, United States; Recruiting
      Margarita Ramos 714-778-1300 Ext. 284 mramos@...


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


      Herbert L. Bonkovsky, M.D., Farmington, Connecticut, 06030, United States; Recruiting
      Michelle Kelly, RN 860-679-8156 mikelley@...


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


      Arnold L. Lentnek, M.D., Marietta, Georgia, 30060, United States; Recruiting
      Dena Mogelnicki 770-793-5975 dena.moon@...


      Ellen B. Hunter, M.D., Boise, Idaho, 83702, United States; Recruiting
      Carrie Frye-Sprague 208-947-0970 cfrye@...


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

      Steven L. Flamm, M.D., Chicago, Illinois, 60611, United States; Recruiting
      Kim Sipich 312-503-0121 k-sipich@...


      Alvaro G. Koch, M.D., Lexington, Kentucky, 40536, United States; Recruiting
      Jeri Reynolds 859-323-6423 jzreyn0@...


      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@...

      Robert M. Be, M.D., Baton Rouge, Louisiana, 70809, United States; Recruiting
      Stacie LaPrarie 225-317-2258 staciel@...


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

      Milton J. Koch, M.D., Silver Spring, Maryland, 20901, United States; Recruiting
      Mary Ellen Royalty, RN 301-681-3329 giresearch2002@...


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

      Nezam Afdhal, M.D., Boston, Massachusetts, 02215, United States; Recruiting
      Christine O'Connor 617-632-1051 coconno2@...


      Jeffrey Rank, M.D., Saint Paul, Minnesota, 55446, United States; Recruiting
      Melissa Weber 612-870-5597 mweber@...

      John B. Gross, M.D., Rochester, Minnesota, 55905-0002, United States; Recruiting
      Stephanie Johnson 507-266-8387


      Adrian Di Bisceglie, M.D., Saint Louis, Missouri, 63104, United States; Recruiting
      Kili Goudey 314-977-9410 goudeykl@...

      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@...

      Ira M. Jacobson, M.D., New York, New York, 10021, United States; Recruiting
      Debra Rovner 212-746-2133 dnr2001@...

      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@...

      John E. Poulous, M.D., Fayetteville, North Carolina, 28304, United States; Recruiting
      Angela Person 910-484-8163 Ext. 3 "aperson-cresearch@...


      Harvey A. Tatum, M.D., Tulsa, Oklahoma, 74104, United States; Recruiting
      Cheryl Holz 918-579-3163 cholz@...


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

      Peter J. Molloy, M.D., Pittsburgh, Pennsylvania, 15224, United States; Recruiting
      Jeannie Flinko, RN 412-917-0331 (pager) jflinko@...


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

      Lawrence D. Wruble, M.D., Memphis, Tennessee, 38120, United States; Recruiting
      Mandy Fletcher 901-747-3630 Ext. 342 afletcher@...


      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@...

      Gary L. Davis, M.D., Dallas, Texas, 75246, United States; Recruiting
      Karla Huang, RN 214-820-6894 karlah@...

      Rise Stribling, M.D., Houston, Texas, 77030, United States; Recruiting
      Patricia Brinegar 713-441-7894 pbrinegar@...


      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@...

      Mitchell Shiffman, M.D., Richmond, Virginia, 23298, United States; Recruiting
      Denice Shelton 804-675-5000 Ext. 3686 denice.shelton@...


      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@...

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