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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment Clinical research trials and Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment. Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment clinical trial. Human subjects frequently get the finest healthcare available for their Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment  Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment
For Condition: Hepatic Cirrhosis,Fibrosis, Liver,Cirrhosis, Liver,Chronic Hepatitis C
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , National Institute of Allergy and Infectious Diseases (NIAID),National Center on Minority Health and Health Disparities (NCMHD),National Cancer Institute (NCI),Hoffmann-La Roche
Synopsis: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic HCV. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age at entry at least 18 years. - Positive for Hepatitis C. - Previous treatment with any interferon or interferon and ribavirin for at least 3 months. - Documented non-response to treatment with interferon. - A liver biopsy demonstrating significant liver scarring. Exclusion Criteria: - No other liver disease. - No unstable major medical diseases or conditions. - No major complications of cirrhosis. - No recent abuse of alcohol or illicit drugs.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregoryEverson, Principal Investigator, UCHSC (University of Colorado)
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Connecticut Health Center
Farmington, Connecticut, 06030
United States
University of California-Irvine/VA Medical Center-Long Beach
Long Beach, California, 90822
United States
University of Texas Southwestern - Dallas
Dallas, Texas, 75390-9195
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
UMass Memorial HealthCare, University Campus
Worcester, Massachusetts, 01655
United States
UCHSC (University of Colorado)
Denver, Colorado, 80262
United States
USC School of Medicine
Los Angeles, California, 90033
United States
Saint Louis University
St. Louis, Missouri, 63104
United States
Medical College of Virginia
Richmond, Virginia, 23298-0341
United States
Lds, Niddk, Nih
Bethesda, Maryland, 20892-1800
United States
Additional Information:
Study ID Numbers: HALT C; N01-DK-9-2326,N01-DK-9-2327,N01-DK-9-2319,N01-DK-9-2322,N01-9-2318,N01-DK-9-2324,N01-DK-9-2328,N01-DK-2325,N01-DK-9-2328,N01-DK-9-2323,N01-DK-9-2321,N01-DK-9-2320
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006164
Other Fibrosis, Liver Studies:
1. Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment
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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment
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