Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01011166
First received: October 2, 2009
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (IFN)/Ribavirin (RBV). These data will guide dose selection for future, longer term studies.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: IDX184
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability will be measured by clinical assessments and standard safety laboratory parameters. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Antiviral activity at Day 15 will be measured by plasma HCV RNA concentration. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antiviral activity at Day 28 will be measured by plasma HCV RNA concentration. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics will be measured by plasma IDX184 and 2'-MeG concentrations. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDX184 50 mg QD + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 50 mg orally once daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)
Experimental: IDX184 50 mg BID + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 50 mg orally twice daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)
Experimental: IDX184 100 mg QD + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 100 mg orally once daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)
Experimental: IDX184 150 mg QD + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 150 mg orally once daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)
Experimental: IDX184 100 mg BID + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 100 mg orally twice daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)
Experimental: IDX184 200 mg QD + P/R
Subjects randomized 4:1 (active:placebo) to receive IDX184 200 mg orally once daily in combination with Peg-IFN/RBV.
Drug: IDX184
4:1 (active:placebo)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be practicing birth control or must not be of childbearing potential
  • Documented chronic hepatitis C, genotype 1

Exclusion Criteria:

  • Previous antiviral treatment for hepatitis C infection
  • Cirrhosis or decompensated liver disease
  • Pregnant or breastfeeding
  • Body Mass Index (BMI) > 35.
  • Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)
  • Clinically significant concomitant disease
  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: NCT01011166

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Missouri
St. Louis, Missouri, United States
United States, North Carolina
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01011166     History of Changes
Other Study ID Numbers: IDX-08C-004
Study First Received: October 2, 2009
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
Chronic Hepatitis C
HepC
Hep C

Additional relevant MeSH terms:
Infection
Communicable Diseases
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

ClinicalTrials.gov processed this record on September 30, 2014