IdB 1016 Treatment for Hepatitis C Disease

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Silymarin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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