NCT00790673

A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety, Tolerability, Biological Activity, and Pharmacokinetics of Orally Administered CF102 in Subjects With Chronic Hepatitis C Genotype 1

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Can-Fite BioPharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and will measure blood concentrations of CF102 at various time points during dosing.

Detailed description

This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1 ratio (8 subjects in each cohort) to receive qd or bid treatment for 15 days with oral CF-102 or with placebo. Dose escalation will occur in 2 sequential cohorts. The decision to continue dosing within a cohort (eg, Subcohort 1a to Subcohort 1b), or to escalate to a new dose level Cohort (eg, Subcohort 1b to Subcohort 2a) will be determined by a blinded independent review of safety data. This review will be conducted by a qualified Safety Review Committee comprising the medical monitor, the consulting toxicologist, and an independent expert clinician. For the first 2 cohorts, subjects will return to the study center for follow-up assessments on Days 8, 15, and 22. Subjects dosed qd will receive a total of 15 doses of CF-102. Subjects dosed bid will receive a total of 29 doses. The 30th dose has been deleted to accommodate PK sampling on the morning of Day 16, 24 hours after the last dose of CF-102. For the 3rd cohorts, subjects will return to the study center for follow-up assessments on weeks 2, 4, 8, 12, 16 and 18.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	CF 102	Oral capsules
DRUG	Placebo	Matching placebo capsules

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2008-11-13
• Last updated: 2015-04-15
• Results posted: 2015-04-15

Locations

1 site across 1 country: Israel