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

August 18, 2016 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

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:

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

Exclusion criteria:

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Drug: IDX184
oral dose, active or placebo
Experimental: Cohort B
Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Drug: IDX184
oral dose, active or placebo
Experimental: Cohort C
Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Drug: IDX184
oral dose, active or placebo
Experimental: Cohort D
Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Drug: IDX184
oral dose, active or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
17 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
Time Frame: Baseline to 4 days
Measures how much virus is in the blood.
Baseline to 4 days

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

December 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2355-003
  • IDX-08C-003

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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