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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014