Phase 2 Completed N=41 Randomized Double-blind Treatment

Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

Chronic Hepatitis C (HCV)

Source: ClinicalTrials.gov NCT00807001 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2010

Primary outcomePrimary: Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events — 5; 2; 3; 3 participants

Summary

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events	5; 2; 3; 3; 5; 1	—
SECONDARY Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)	-0.1; -0.5; -0.7; -0.6; -0.7	—

Eligibility Criteria

Inclusion criteria

18-65 years old
Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
Plasma HCV RNA ≥ 5 log10 IU/mL
HCV genotype 1

Exclusion criteria

Received prior antiviral treatment for hepatitis C infection
Subject is pregnant or breastfeeding
Body Mass Index (BMI) > 32
Currently abusing alcohol or illicit drugs
Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00807001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.