IdB 1016 Treatment for Hepatitis C Disease

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00055445
Study type	Interventional
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	November 2003
Completion date	April 2006

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