| |
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, said Dr Doug Dieterich, Mt Sinai Hospital Medical Center in New York City, a site for the study..."
"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,
Genders Eligible for Study: 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
973-235-5000
or 800-526-6367 (FOR US ONLY)
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
|
|
| |
| |
|
|
|
