NCT01011166

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

October 2, 2009

Last Update Submit

April 22, 2015

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis CHepCHep C

Outcome Measures

Primary Outcomes (5)

  • Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15

    Baseline and Day 15

  • Percentage of participants experiencing adverse events (AEs)

    Up to 28 days

  • Percentage of participants experiencing serious adverse events (SAEs)

    Up to 28 days

  • Percentage of participants experiencing dose-limiting toxicities (DLTs)

    Up to 28 days

  • Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Up to 28 days

Secondary Outcomes (12)

  • Change in HCV RNA level from Baseline to Day 28

    Baseline and Day 28

  • Percentage of participants with undetectable HCV RNA at Day 15

    Day 15

  • Percentage of participants with undetectable HCV RNA at Day 28

    Day 28

  • Percentage of participants experiencing virologic breakthrough while on study therapy

    Up to 28 days

  • Change in alanine aminotransferase (ALT) level from Baseline to Day 15

    Baseline and Day 15

  • +7 more secondary outcomes

Study Arms (6)

IDX184 50 mg QD + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

IDX184 100 mg QD + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

IDX184 100 mg BID + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

IDX184 150 mg QD + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

IDX184 200 mg QD + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

IDX184 200 mg BID + Peg-IFN/RBV

EXPERIMENTAL

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: IDX184Drug: PlaceboBiological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

Interventions

IDX184DRUG

IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.

IDX184 100 mg BID + Peg-IFN/RBVIDX184 100 mg QD + Peg-IFN/RBVIDX184 150 mg QD + Peg-IFN/RBVIDX184 200 mg BID + Peg-IFN/RBVIDX184 200 mg QD + Peg-IFN/RBVIDX184 50 mg QD + Peg-IFN/RBV
PlaceboDRUG

Placebo white opaque capsules taken by mouth from Day 1 to Day 14.

IDX184 100 mg BID + Peg-IFN/RBVIDX184 100 mg QD + Peg-IFN/RBVIDX184 150 mg QD + Peg-IFN/RBVIDX184 200 mg BID + Peg-IFN/RBVIDX184 200 mg QD + Peg-IFN/RBVIDX184 50 mg QD + Peg-IFN/RBV
Peginterferon alfa-2a (Peg-IFN)BIOLOGICAL

Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.

Also known as: Pegasys
IDX184 100 mg BID + Peg-IFN/RBVIDX184 100 mg QD + Peg-IFN/RBVIDX184 150 mg QD + Peg-IFN/RBVIDX184 200 mg BID + Peg-IFN/RBVIDX184 200 mg QD + Peg-IFN/RBVIDX184 50 mg QD + Peg-IFN/RBV
Ribavirin (RBV)DRUG

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.

IDX184 100 mg BID + Peg-IFN/RBVIDX184 100 mg QD + Peg-IFN/RBVIDX184 150 mg QD + Peg-IFN/RBVIDX184 200 mg BID + Peg-IFN/RBVIDX184 200 mg QD + Peg-IFN/RBVIDX184 50 mg QD + Peg-IFN/RBV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25.

    PMID: 23439365RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

IDX184peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

November 11, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

April 23, 2015

Record last verified: 2015-04