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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 2, 2009
Last Updated Date	July 5, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01011166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis C Infection
Intervention ^ICMJE	Drug: IDX184 4:1 (active:placebo)
Study Arm (s)	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. Intervention: Drug: IDX184 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. Intervention: Drug: IDX184 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. Intervention: Drug: IDX184 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. Intervention: Drug: IDX184 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. Intervention: Drug: IDX184 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. Intervention: Drug: IDX184
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01011166
Other Study ID Numbers ^ICMJE	IDX-08C-004
Has Data Monitoring Committee	No
Responsible Party	Idenix Pharmaceuticals
Study Sponsor ^ICMJE	Idenix Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Idenix Pharmaceuticals
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top