NCT00807001

A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C

Completed Phase 1/Phase 2 Results posted Last updated 18 August 2016

What this trial tests

Phase 1/Phase 2 trial testing IDX184 in Chronic Hepatitis C (HCV) in 41 participants. Completed in 1 July 2009.

Timeline

1 December 2008

Primary endpoint
1 July 2009

1 July 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	1 December 2008
Primary completion	1 July 2009
Estimated completion	1 July 2009

Drugs / interventions tested

• IDX184 — full drug profile →

Conditions studied

• Chronic Hepatitis C (HCV) — all drugs for Chronic Hepatitis C (HCV) →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis C (HCV). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
  Time frame: 17 days
  Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.