IdB 1016 Treatment for Hepatitis C Disease

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00055445
First received: March 3, 2003
Last updated: August 17, 2006
Last verified: July 2006
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: IdB 1016
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IdB 1016 in Hepatitis C

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 45
Study Start Date: November 2003
Estimated Study Completion Date: April 2006
Detailed Description:

Results from two open label and four randomized placebo-controlled studies in patients with liver disease of diverse etiology suggest that IdB 1016 (oral silybin-phosphatidylcholine phytosome) is well tolerated and significantly improves serum liver enzyme levels. However, IdB 1016 dosing in these studies ranged from 314 mg bid to 314 mg tid, which is below Phase I doses that were well tolerated in healthy volunteers. None of the studies tested the safety and efficacy of IdB 1016 strictly in patients with chronic hepatitis C disease or measured post-treatment histologic changes.

This study will be an open label, randomized, dose-finding study. There will be three arms corresponding to three different IdB 1016 doses: 314 mg, 624 mg, and 942 mg tid. Each arm will have 15 patients diagnosed with chronic hepatitis C and will be stratified to five patients with fibrosis stage II (periportal fibrosis), five patients with fibrosis stage III (bridging fibrosis), and five patients with fibrosis stage IV (compensated cirrhosis). The treatment duration will be 12 weeks. Patients will be followed for an additional 4 weeks after treatment cessation to assess residual effects of measured parameters. Patients will have clinic visits on Day -21 (screening), Day 1 (treatment initiation), Day 29, Day 57, Day 85 (end of treatment), and Day 113 (follow-up after washout).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055445

Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Investigators
Principal Investigator: Kris V. Kowdley, M.D. University of Washington
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00055445     History of Changes
Other Study ID Numbers: R21 AT000992-01A1, IdB-1016-UW-001
Study First Received: March 3, 2003
Last Updated: August 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Complementary Therapies
IdB 1016
Silybin
Antioxidant
Hepatitis C Virus
Phosphatidylcholine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on July 31, 2014