IdB 1016 Treatment for Hepatitis C Disease

August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)

IdB 1016 in Hepatitis C

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Kris V. Kowdley, M.D., University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

March 3, 2003

First Submitted That Met QC Criteria

March 3, 2003

First Posted (Estimate)

March 4, 2003

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT000992-01A1 (U.S. NIH Grant/Contract)
  • IdB-1016-UW-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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