IdB 1016 Treatment for Hepatitis C Disease

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

This study will measure the safety and tolerability of three different doses of IdB 1016 in patients with hepatitis C disease who have not responded to or are poor candidates for interferon-based therapies. NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL CENTER IN SEATTLE

Key facts

Study ID

NCT00055445

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

45

Starts

2003-11-01

Expected to finish

2006-04-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV infection according to ELISA-2
• Detectable HCV RNA PCR as measured within the previous 6 months
• Poor responders to, inadequate candidates for, or unwilling to use interferon-based therapies
• Serum ALT >= 1.3 times above normal
• Persistently elevated serum ALT levels according to two measures in the previous 12 months
• Evidence of stage II (periportal fibrosis), III (bridging fibrosis), or IV (compensated cirrhosis) in the Batts-Ludwig scoring system according to a liver biopsy performed in the last 2 (stage II and III patients) to 5 (stage IV patients) years. Patients with clinical signs of compensated cirrhosis (portal hypertension, non-bleeding varices) do not require a biopsy.
• Able and willing to follow protocol directions for the duration of the study
• Able and willing to maintain a consistent lifestyle routine (e.g., diet, exercise, medications, and dietary supplements) and sleep schedule for the duration of the study
• Able and willing to stop taking dietary supplements outside the study protocol for the duration of the study
• Able and willing to practice two methods of contraception during the study period, including the 4 week follow-up. This applies to women with childbearing potential and men whose sexual partners have childbearing potential.

You may not qualify if…

• Pregnant or breastfeeding
• Liver synthetic dysfunction (albumin < 3.2 g/dL, total bilirubin > 3.0 mg/dL, prothrombin time > 1.5 seconds prolonged)
• History of ascites, variceal bleeding, encephalopathy, jaundice, or extrahepatic biliary obstruction
• History of uncontrolled diabetes mellitus
• Known concomitant acute or chronic viral liver infections (e.g., hepatitis A, hepatitis B, Epstein-Barr, or cytomegalovirus)
• Concomitant autoimmune and inflammatory disease (e.g., rheumatoid arthritis, lupus)
• Other types of concomitant liver disease
• HIV-1 coinfection
• Chronic use of hepatotoxic drugs (e.g., acetaminophen)
• Interferon-based therapies in the past 6 months
• Alcohol consumption within 3 months prior to entry. Patients with a history of alcohol abuse should be at least 2 years into recovery.
• Use of recreational oral or IV drugs. Patients with a history of drug addiction should be at least 2 years into recovery.
• History of untreated malignancy
• Remission from previous malignant neoplasms <= 6 months
• History of significant renal, endocrine, cardiac, or pulmonary disease
• Use of supplements containing compounds derived from milk thistle
• Proven allergy to milk thistle or any derived compounds
• Subjects taking warfarin or coumadin due to silybin's potential interactions with cytochrome CYP 29C
• Any condition or concomitant medication or supplement that could hinder the outcomes of the study or the safety of the patient as determined by the principal investigator

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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