IdB 1016 Treatment for Hepatitis C Disease

NCT00055445 | Completed Phase 1

• 2 other identifiers: R21AT000992-01A1IdB-1016-UW-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatitis C, Chronic

Keywords

Complementary Therapies; IdB 1016; Silybin; Antioxidant; Hepatitis C Virus; Phosphatidylcholine

Interventions

IdB 1016 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98105, United States

Location

Related Publications (11)

• Carini R, Comoglio A, Albano E, Poli G. Lipid peroxidation and irreversible damage in the rat hepatocyte model. Protection by the silybin-phospholipid complex IdB 1016. Biochem Pharmacol. 1992 May 28;43(10):2111-5. doi: 10.1016/0006-2952(92)90168-i.

  PMID: 1599497 BACKGROUND

• Comoglio A, Tomasi A, Malandrino S, Poli G, Albano E. Scavenging effect of silipide, a new silybin-phospholipid complex, on ethanol-derived free radicals. Biochem Pharmacol. 1995 Oct 12;50(8):1313-6. doi: 10.1016/0006-2952(95)02001-s.

  PMID: 7488251 BACKGROUND

• Conti M, Malandrino S, Magistretti MJ. Protective activity of silipide on liver damage in rodents. Jpn J Pharmacol. 1992 Dec;60(4):315-21. doi: 10.1254/jjp.60.315.

  PMID: 1287266 BACKGROUND

• Edwards J, Grange LL, Wang M, Reyes E. Fetoprotectivity of the flavanolignan compound siliphos against ethanol-induced toxicity. Phytother Res. 2000 Nov;14(7):517-21. doi: 10.1002/1099-1573(200011)14:73.0.co;2-w.

  PMID: 11054841 BACKGROUND

• Morazzoni P, Montalbetti A, Malandrino S, Pifferi G. Comparative pharmacokinetics of silipide and silymarin in rats. Eur J Drug Metab Pharmacokinet. 1993 Jul-Sep;18(3):289-97. doi: 10.1007/BF03188811.

  PMID: 8149949 BACKGROUND

• Morazzoni P, Magistretti MJ, Giachetti C, Zanolo G. Comparative bioavailability of Silipide, a new flavanolignan complex, in rats. Eur J Drug Metab Pharmacokinet. 1992 Jan-Mar;17(1):39-44. doi: 10.1007/BF03189986.

  PMID: 1499596 BACKGROUND

• Comoglio A, Leonarduzzi G, Carini R, Busolin D, Basaga H, Albano E, Tomasi A, Poli G, Morazzoni P, Magistretti MJ. Studies on the antioxidant and free radical scavenging properties of IdB 1016 a new flavanolignan complex. Free Radic Res Commun. 1990;11(1-3):109-15. doi: 10.3109/10715769009109673.

  PMID: 2074043 BACKGROUND

• Barzaghi N, Crema F, Gatti G, Pifferi G, Perucca E. Pharmacokinetic studies on IdB 1016, a silybin- phosphatidylcholine complex, in healthy human subjects. Eur J Drug Metab Pharmacokinet. 1990 Oct-Dec;15(4):333-8. doi: 10.1007/BF03190223.

  PMID: 2088770 BACKGROUND

• Schandalik R, Perucca E. Pharmacokinetics of silybin following oral administration of silipide in patients with extrahepatic biliary obstruction. Drugs Exp Clin Res. 1994;20(1):37-42.

  PMID: 7924893 BACKGROUND

• Schandalik R, Gatti G, Perucca E. Pharmacokinetics of silybin in bile following administration of silipide and silymarin in cholecystectomy patients. Arzneimittelforschung. 1992 Jul;42(7):964-8.

  PMID: 1329780 BACKGROUND

• Buzzelli G, Moscarella S, Giusti A, Duchini A, Marena C, Lampertico M. A pilot study on the liver protective effect of silybin-phosphatidylcholine complex (IdB1016) in chronic active hepatitis. Int J Clin Pharmacol Ther Toxicol. 1993 Sep;31(9):456-60.

  PMID: 8225695 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

IdB 1016

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kris V. Kowdley, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 3, 2003
• First Posted: March 4, 2003
• Study Start: November 1, 2003
• Study Completion: April 1, 2006
• Last Updated: August 18, 2006

Record last verified: 2006-07

Locations

US (1)