Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01371604

Enrollment

Registered

2011-06-13

Start date

2011-07-31

Completion date

2014-10-31

Last updated

2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, HCV, treatment-naive

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.

Interventions

DRUGIDX184

IDX184 50 mg tablet administered orally

BIOLOGICALPeginterferon alfa-2a (Peg-IFN)

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

DRUGRibavirin (RBV)

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.

DRUGPlacebo

Matching placebo to IDX184 50 mg tablet administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment	Weeks 24 or 48
Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4	Week 4
Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)	Weeks 48 or 72
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026