Gamma Interferon Therapy for Chronic Hepatitis C

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00028275
• Date of registration: 18/12/2001
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Gamma Interferon Therapy for Chronic Hepatitis C
• Scientific title: Pilot Studies of Gamma Interferon Therapy for Chronic Hepatitis C
• Date of first enrolment: December 2001
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00028275
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Age 18 years or above, 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 IU/L).

Presence of anti-HCV in serum.

Presence of HCV RNA genotype1 in serum at levels above 10,000 copies/ml.

Previous adequate therapy with alpha interferon and ribavirin without a sustained
virological response. An adequate course of therapy is defined as at least 24 weeks of
alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in
starting doses of at least 1000 mg daily. Patients who initiated therapy at these doses,
but required dose modification due to side effects will also be eligible.

Written informed consent.

EXCLUSION CRITERIA:

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 in 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, ischemic heart disease, angina pectoris, cerebrovascular disease, renal
failure (creatinine clearance less than 50 ml/min), organ transplantation, serious
psychiatric disease or depression.

Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%),
neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than
70,000 cells/mm(3)).

Evidence of another form of liver disease in addition to viral hepatitis (for example
autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis,
alpha-1-antitrypsin deficiency).

Active substance abuse, such as alcohol, inhaled or injection drugs within the previous
six months.

Serious autoimmune disease that, in the opinion of the investigators, might be worsened by
interferon therapy, such as lupus erythematous, rheumatoid arthritis or Crohn's disease.

Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50
ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating
a mass suggestive of liver cancer.

Human immunodeficiency virus infection, as shown by presence of anti-HIV.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C

Intervention(s)

Drug: Gamma Interferon 1b

Secondary ID(s)

02-DK-0072

020072

Source(s) of Monetary Support

Please refer to primary and secondary sponsors