Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin - Full Text View

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin

U.S. FDA Resources

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

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:

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
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 June 18, 2013