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Fwd: NATAP: Latino Study-Pegasys+RBV in Naives Geno 1

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  • claudine intexas
    nataphcv@natap.org wrote:Date: Mon, 31 Oct 2005 12:41:45 EST To: nataphcv@natap.org, nataphcvhiv@natap.org, natapdoctors@natap.org, natapindustry@natap.org CC:
    Message 1 of 1 , Oct 31, 2005
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      nataphcv@... wrote:Date: Mon, 31 Oct 2005 12:41:45 EST
      To: nataphcv@..., nataphcvhiv@...,
      natapdoctors@..., natapindustry@...
      CC:
      From: nataphcv@...
      Subject: NATAP: Latino Study-Pegasys+RBV in Naives Geno 1

      NATAP http://natap.org/
      _______________________________________________
      Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1

      "....During the course of the 48-week study, patients will receive about $25,000 in free medications and an additional $20,000 to $25,000 in free doctor examinations and laboratory tests..."

      "UMC seeks hepatitis C patients"
      Study to research different responses to treatment in Hispanics and whites.

      See Study Protocol at end of this article.
      By Barbara Anderson / The Fresno BeeOctober 31, 2005, 5:32 AM)

      Who should be tested?
      • Anyone who ever injected illegal drugs, including those who injected once or a few times many years ago.
      • Anyone who received a blood transfusion or organ transplant before July 1992.
      • Anyone who received clotting factor concentrates before 1987.
      • Anyone who was ever on long-term dialysis.
      • Children born to hepatitis C-positive women.
      • Health-care, emergency medical and public safety workers after needle sticks or other exposures to hepatitis C-positive blood.
      • Anyone with evidence of chronic liver disease.

      Information about enrolling in the Hepatitis C Latino Study at University Medical Center is available by calling (559) 459-3882. Source: Federal Centers for Disease Control and Prevention

      Doctors at University Medical Center are looking for more patients like Ralph Salazar.

      Salazar, 49, of Fresno, agreed to participate in a nationwide hepatitis C clinical trial when doctors at UMC approached him earlier this fall.

      Hispanics and non-Hispanic whites with hepatitis C are needed for a Hepatitis C Latino Study sponsored by the health-care company Roche. The trial will look at the success of hepatitis C drugs in treating Hispanic patients versus non-Hispanic whites.

      Researchers suspect there may be differences in the ways Hispanic and non-Hispanic white patients respond to treatment. Previous studies have shown patients who are black are less likely to be cured by drug therapy than white patients.

      UMC is one of 60 medical centers in the country signing up participants for the Latino Study. Researchers hope to enroll 270 Hispanics and 270 non-Hispanic whites nationwide.

      As of Oct. 24, the study included 244 non-Hispanic whites and 135 Hispanics. UMC had enrolled 15 patients, all of whom are Hispanic.

      Those with hepatitis C in the Central San Joaquin Valley who are interested in joining the study shouldn't wait. Enrollment may end nationwide in the next six weeks, said Dr. Muhammad Y. Sheikh, principal study investigator in Fresno and chief of gastroenterology and hepatology at UMC.

      According to the federal Centers for Disease Control and Prevention, an estimated 3.9 million Americans may be infected with the hepatitis C virus. (More like 5 million)

      The Fresno County Selected Communicable Diseases Report for September 2005 shows 470 cases of hepatitis C reported in the county in 2004 and 289 cases thus far in 2005.

      The hepatitis C virus causes inflammation of the liver. Damage from the virus can lead to cirrhosis (scarring of the liver) and eventually may lead to liver cancer.

      The virus is spread through infected blood.

      Those participating in the study take two anti-viral medications — ribavirin pills and interferon shots. The treatment is the standard care provided for hepatitis C.

      During the course of the 48-week study, patients will receive about $25,000 in free medications and an additional $20,000 to $25,000 in free doctor examinations and laboratory tests, said Dr. Douglas Dieterich, one of the trial investigators and professor of medicine at Mount Sinai School of Medicine in New York City.
      The Latino Study is "a marvelous opportunity to find out what the differences are in response to interferon therapy for hepatitis C in the Latino population," Dieterich said.

      Getting set up to take a blood pressure reading, Dr. Keleni Tukia of the University Medical Center's Gastroenterology Department, left, works with hepatitis C patient Ralph Salazar, who is participating in a nationwide Hepatitis C Latino Study.

      Salazar, a disabled warehouseman, said he didn't hesitate when UMC doctors asked him to join the study.
      For the first eight weeks, he came to the hospital every two weeks for blood tests. He now sees doctors once a month. After less than eight weeks of treatment, Salazar said the level of virus in his blood had dropped significantly. "This medication is working wonders."

      Salazar doesn't know how or when he was infected: "Let's just say there were wrong choices made in my earlier days."

      He learned he had hepatitis C from blood tests taken before a colonoscopy. Hepatitis C is often described as a "silent killer," because patients don't experience symptoms until later stages of the disease.
      Anyone who has "thoughts at all that you may have been exposed, get in here" for testing, Salazar said.
      Potential participants in the Latino Study are given screening tests, including blood tests, chest X-rays, an electrocardiogram and an eye examination. They also have a liver biopsy to determine the extent of their disease, Sheikh said.

      The liver biopsy is an outpatient procedure. The test takes only a few minutes to complete, but patients remain at the hospital for six hours of observation, he said.

      Not everyone with hepatitis C qualifies for the study. For example, patients cannot be actively using alcohol or illicit drugs, Sheikh said.

      Researchers should know the results of the study in 2007.

      Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1

      This study is currently recruiting patients.
      Verified by Hoffmann-La Roche October 2005
      Sponsored by: Hoffmann-La Roche

      This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C, genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

      Eligibility
      Ages Eligible for Study: 18 Years  -  65 Years,Â
      Genders Eligible for Study:Â Both

      Criteria
      Inclusion Criteria:


      * adult patients 18-65 years of age
      * CHC, genotype 1
      * serologic evidence of CHC infection by an antibody test
      * chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
      * compensated liver disease
      * use of 2 forms of contraception during the study in both men and women


      Exclusion Criteria:


      * previous interferon or ribavirin therapy
      * systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
      * medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
      * decompensated liver disease
      * women who are pregnant or breastfeeding


      Location and Contact Information

      Please reference Study ID Number: RLI_ML18179 Â Â Â
      973-235-5000Â
      or    800-526-6367 (FOR US ONLY)Â

      Arizona
            Tucson, Arizona, 85712, United States; Recruiting

            Scottsdale, Arizona, 85283, United States; Recruiting

      California
            San Bernardino, California, 92404, United States; Recruiting

            Redlands, California, 92373, United States; Recruiting

            Anaheim, California, 92801, United States; Recruiting

            Palo Alto, California, 94304-1509, United States; Recruiting

            San Francisco, California, 94110, United States; Recruiting

            Lancaster, California, 93534, United States; Recruiting

            Los Angeles, California, 90095, United States; Recruiting

            Fresno, California, 93702, United States; Recruiting

            San Diego, California, 92161, United States; Recruiting

            Ventura, California, 93003, United States; Recruiting

            San Diego, California, 92103-8465, United States; Recruiting

            San Luis Obispo, California, 93401, United States; Recruiting

            San Diego, California, 92123, United States; Recruiting

            San Mateo, California, 94403, United States; Terminated

            San Diego, California, 92120, United States; Recruiting

            Sacramento, California, 95817, United States; Recruiting

            Los Angeles, California, 90033, United States; Recruiting

            Fountain Valley, California, 92708, United States; Not yet recruiting

            Los Angeles, California, 90022, United States; Recruiting

      Colorado
            Pueblo, Colorado, 81008, United States; Recruiting

      Florida
            North Miami, Florida, 33162, United States; Recruiting

            Miami, Florida, 33125, United States; Recruiting

            Boca Raton, Florida, 33428, United States; Recruiting

            Bradenton, Florida, 34205, United States; Recruiting

            Miami, Florida, 33156, United States; Terminated

            Plantation, Florida, 33324, United States; Recruiting

      Georgia
            Austell, Georgia, 30106, United States; Recruiting

      Illinois
            Chicago, Illinois, 60612, United States; Recruiting

            Chicago, Illinois, 60637, United States; Recruiting

            Gurnee, Illinois, 60031, United States; Recruiting

      Indiana
            Indianapolis, Indiana, 46202, United States; Recruiting

      Louisiana
            New Orleans, Louisiana, 70115, United States; Recruiting

            New Orleans, Louisiana, 70115, United States; Recruiting

      Maryland
            Baltimore, Maryland, 21205, United States; Recruiting

      Massachusetts
            Framingham, Massachusetts, 01702, United States; Recruiting

            Worcester, Massachusetts, 01655, United States; Recruiting

      Missouri
            St. Louis, Missouri, 63110, United States; Recruiting

      New Jersey
            Vineland, New Jersey, 08043, United States; Recruiting

      New Mexico
            Santa Fe, New Mexico, 87503, United States; Terminated

      New York
            Bayside, New York, 11358, United States; Recruiting

            Rochester, New York, 14618, United States; Recruiting

            Brooklyn, New York, 11203, United States; Terminated

            New York, New York, 10029, United States; Recruiting

      North Carolina
            Chapel Hill, North Carolina, 27599-7080, United States; Recruiting

            Fayetteville, North Carolina, 28304, United States; Not yet recruiting

      Pennsylvania
            Philadelphia, Pennsylvania, 19141, United States; Recruiting

            Philadelphia, Pennsylvania, 19107, United States; Recruiting

      Tennessee
            Nashville, Tennessee, 37211, United States; Recruiting

      Texas
            Austin, Texas, 78758, United States; Terminated

            Houston, Texas, 77030, United States; Recruiting

            Galveston, Texas, 77555-0764, United States; Recruiting

            San Antonio, Texas, 78258, United States; Recruiting

            Houston, Texas, 77030, United States; Recruiting

            Fort Sam Houston, Texas, 78234-3879, United States; Recruiting

            Fort Worth, Texas, 76107, United States; Recruiting

            Dallas, Texas, 75208, United States; Recruiting

            Houston, Texas, 77090, United States; Not yet recruiting

      Utah
            Salt Lake City, Utah, 84121, United States; Recruiting

      Virginia
            Fairfax, Virginia, 22031, United States; Recruiting

      Washington
            Seattle, Washington, 98133, United States; Recruiting

            Tacoma, Washington, 98405, United States; Recruiting

      Puerto Rico
            Santurce, 00909, Puerto Rico; Recruiting

            Ponce, 00716, Puerto Rico; Recruiting _______________________________________________
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