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

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ClinicalTrials.gov Identifier: NCT00807001
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : November 4, 2010
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C (HCV) Drug: IDX184 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00807001     History of Changes
Other Study ID Numbers: 2355-003
IDX-08C-003
First Posted: December 11, 2008    Key Record Dates
Results First Posted: November 4, 2010
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis C, HCV, treatment-naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections