Search / Trial NCT00001729

Combination Drug Therapy for Patients With Hepatitis C

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Nov 3, 1999

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Cirrhosis Liver Disease Hemolytic Anemia Liver Biopsy Ribavirin Alpha Interferon Viral Hepatitis Hepatitis C Virus Chronic Hepatitis Antiviral Agents

Description

Between 60 and 90 patients with chronic hepatitis C will be enrolled in a study of the combination of alpha interferon and ribavirin for 12 months with early discontinuation of therapy and randomization to receive either ribavirin alone or placebo for patients who do not respond within 6 months of starting therapy. Adult patients will be chosen who have chronic hepatitis C, HCV RNA in serum, and elevations in serum aminotransferases. Patients who have received alpha interferon in the past will be eligible if they did not have a sustained response to their previous course of interferon. Afte...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Age above 18 years, male or female.
  • Serum alanine or asparate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 U/L) on an average of three determinations taken during the previous 6 months. The mean of the three determinations will be defined as "baseline" levels.
  • Presence of anti-HCV and HCV RNA in serum tested at least once during the previous six months.
  • Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22).
  • Written informed consent.
  • EXCLUSION CRITERIA:
  • If previously treated with interferon or ribavirin, must not have a lack of sustained virological response as shown by the presence of HCV RNA in serum six months after stopping therapy. Patients must not have received the combination of alpha interferon and ribavirin in the past.
  • Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
  • Pregnancy or, in women of child-bearing potential or spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermacide, or birth control pills, or an intrauterine device.
  • Significant systemic or major illnesses other than liver disease, including congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, and angina pectoris.
  • Pre-existing anemia (hematocrit less than 36% for men and less than 34% for women) or known history of hemolytic anemia.
  • Antiviral or immunosuppressive therapy within the last 6 months.
  • Evidence of another form of liver disease in addition to viral hepatitis (e.g., autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency).
  • Any evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
  • Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
  • Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50 ng/ml (normal is less than 9 ng/ml) and /or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
  • Clinical gout.

Attachments

readout_NCT00001729_2024-07-14.pdf

4.5 MB

NCT00001729_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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6
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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