Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01371604
First received: June 9, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C infection.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve 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 [ Time Frame: 12 weeks and up to 72 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects with adverse events as a measure of safety and tolerability


Secondary Outcome Measures:
  • Antiviral Activity [ Time Frame: 12 weeks and up to 72 weeks ] [ Designated as safety issue: No ]
    Plasma hepatitis C virus ribonucleic acid (HCV RNA)


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: IDX184

12 weeks of 50 mg IDX184 QD + Peg-IFN/RBV

Peg-IFN/RBV continued for an additional 12 or 36 weeks

Experimental: Arm B Drug: IDX184

12 weeks of 100 mg IDX184 QD + Peg-IFN/RBV

Peg-IFN/RBV continued for an additional 12 or 36 week


  Eligibility

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

Inclusion Criteria:

  • Males and females with documented genotype 1, chronic hepatitis C infection.
  • Subjects must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
  • Written informed consent by subject.

Exclusion Criteria:

  • Prior HCV treatment.
  • Pregnant or breastfeeding.
  • Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen (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: NCT01371604

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, Colorado
Denver, Colorado, United States
United States, Florida
Bradenton, Florida, United States
Orlando, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Newport News, Virginia, United States
Richmond, Virginia, United States
Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Israel
Haifa, Israel
Jerusalem, Israel
Nazaeth, Israel
Safed, Israel
TelAviv, Israel
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01371604     History of Changes
Other Study ID Numbers: IDX-08C-005
Study First Received: June 9, 2011
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Interferons
Ribavirin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014