NCT01371604

Brief Summary

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 virus (HCV) infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration 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

June 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1.7 years

First QC Date

June 9, 2011

Last Update Submit

February 5, 2015

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis CHCVtreatment-naive

Outcome Measures

Primary Outcomes (4)

  • Percentage of participants who experience a serious adverse event

    Up to Week 16 and end of treatment (Weeks 24 or 48)

  • Percentage of participants who experience an adverse event

    16 weeks

  • Percentage of participants who experience a grade 1-4 laboratory abnormality

    16 weeks

  • Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12

    Week 12

Secondary Outcomes (6)

  • Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4

    Week 4

  • Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment

    Weeks 24 or 48

  • Percentage of participants who achieve sustained virologic response (SVR)

    24 weeks after the last dose (Weeks 48 or 72)

  • Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4

    Week 4

  • Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment

    Weeks 24 or 48

  • +1 more secondary outcomes

Study Arms (2)

IDX184 50 mg + Peg-IFN/RBV

EXPERIMENTAL

IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

Drug: IDX184Biological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)Drug: Placebo

IDX184 100 mg + Peg-IFN/RBV

EXPERIMENTAL

IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

Drug: IDX184Biological: Peginterferon alfa-2a (Peg-IFN)Drug: Ribavirin (RBV)

Interventions

IDX184DRUG

IDX184 50 mg tablet administered orally

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

Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly

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

Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.

IDX184 100 mg + Peg-IFN/RBVIDX184 50 mg + Peg-IFN/RBV
PlaceboDRUG

Matching placebo to IDX184 50 mg tablet administered orally

IDX184 50 mg + Peg-IFN/RBV

Eligibility Criteria

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

You may qualify if:

  • Males and females with documented genotype 1, chronic hepatitis C infection.
  • Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
  • Has not received prior antiviral treatment for HCV.
  • Written informed consent by participant.

You may not qualify if:

  • Pregnant or breastfeeding.
  • Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

IDX184peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 13, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

October 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02