Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

April 22, 2015 updated by: Merck Sharp & Dohme LLC

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

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has documented chronic HCV GT1 infection
  • Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy

Exclusion Criteria:

  • Has received previous antiviral treatment for HCV infection
  • Has cirrhosis or decompensated liver disease
  • Is pregnant or breastfeeding
  • Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV)
  • Has clinically significant concomitant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Experimental: IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Experimental: IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Experimental: IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Experimental: IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Experimental: IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Drug: IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Drug: Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological: Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants experiencing serious adverse events (SAEs)
Time Frame: Up to 28 days
Up to 28 days
Percentage of participants experiencing adverse events (AEs)
Time Frame: Up to 28 days
Up to 28 days
Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
Time Frame: Baseline and Day 15
Baseline and Day 15
Percentage of participants experiencing dose-limiting toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HCV RNA level from Baseline to Day 28
Time Frame: Baseline and Day 28
Baseline and Day 28
Percentage of participants with undetectable HCV RNA at Day 15
Time Frame: Day 15
Day 15
Percentage of participants with undetectable HCV RNA at Day 28
Time Frame: Day 28
Day 28
Percentage of participants experiencing virologic breakthrough while on study therapy
Time Frame: Up to 28 days
Up to 28 days
Change in alanine aminotransferase (ALT) level from Baseline to Day 15
Time Frame: Baseline and Day 15
Baseline and Day 15
Change in ALT level from Baseline to Day 28
Time Frame: Baseline and Day 28
Baseline and Day 28
Maximum concentration (Cmax)
Time Frame: Up to 28 days
Up to 28 days
Time to maximum concentration (Tmax)
Time Frame: Up to 28 days
Up to 28 days
Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)
Time Frame: Up to 28 days
Up to 28 days
AUC from time zero to infinity (AUC0-~)
Time Frame: Up to 28 days
Up to 28 days
Trough concentration (Ctrough)
Time Frame: Up to 28 days
Up to 28 days
Observed terminal half-life (Thalf)
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2355-004
  • IDX-08C-004 (Other Identifier: Idenix Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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