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Home > "S" Clinical Trials Conditions > Study of FK788 in Subjects with Chronic Hepatitis C Virus Infection  Study of FK788 in Subjects with Chronic Hepatitis C Virus Infection
Study of FK788 in Subjects with Chronic Hepatitis C Virus Infection
For Condition: Hepatitis C
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. ,
Synopsis: The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.
Details: This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: The following criteria is a brief summary of Criterion required for trial participation. Inclusion Criteria - Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy - Has positive HCV RNA by RT-PCR - Has abnormal ALT levels (at least 2 X ULN) - Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation - Has normal liver function indicated by: PT =< 2 sec. prolonged compared to the ULN, Albumin >= 3.5 g/dL, Total bilirubin =< 1.5 mg/dL - ANA titer =< 1:160 Exclusion Criteria - Has positive skin test for tuberculosis - Has ALT value >= 300 IU/L - Has abnormal hematological parameters indicated by: ANC < 1500/mm3 and Platelets < 100,000/mm3 - Has creatinine > 1.5 X ULN - AFP > 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound - Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies
Total Enrollment: 48
Location and Contact Information:
Thomas Jefferson University, Gastroenterology and Hepatology
Philadelphia, Pennsylvania, 19107
United States
Carolinas Center for Liver Disease
Charlotte, North Carolina, 28203
United States
Northwest Medical Specialties, PLLC Infections Limited, P.S.
Tacoma, Washington, 98405
United States
Rocky Mount Gastroenterology
Lakewood, Colorado, 80215
United States
University of Florida and Shands Hospital
Gainesville, Florida, 32610
United States
Liver Center BIDMC - Harvard
Boston, Massachusetts, 02215
United States
Liver Center Huntington Memorial Hospital
Pasadena, California, 91105
United States
Duke University
Durham, North Carolina, 27705
United States
Gastroenterology and Hepatology
Kansas City, Missouri, 64131
United States
Additional Information:
Study ID Numbers: FA-788-0004;
Study Start Date: October 2002
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047814
Other Hepatitis C Studies:
1. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
2. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
3. Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients with HIV and Hepatitis C Virus
4. Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected with HCV Genotype 2 or 3
5. Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection
Related Studies:
Other Hepatitis C Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Study of FK788 in Subjects with Chronic Hepatitis C Virus Infection
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