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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00807001
First received: December 10, 2008
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Chronic Hepatitis C (HCV)
Drug: IDX184
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
    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:
  • Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid) [ Time Frame: Baseline to 4 days ] [ Designated as safety issue: No ]
    Measures how much virus is in the blood.


Enrollment: 41
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807001

  Show 24 Study Locations
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00807001     History of Changes
Other Study ID Numbers: IDX-08C-003
Study First Received: December 10, 2008
Results First Received: October 8, 2010
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
European Union: National Health Authorities.

Keywords provided by Idenix Pharmaceuticals:
Hepatitis C, HCV, treatment-naive

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

ClinicalTrials.gov processed this record on April 22, 2014