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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01011166

Enrollment

Registered

2009-11-11

Start date

2009-11-30

Completion date

2010-07-31

Last updated

2015-04-23

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

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis C, HepC, Hep C

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.

Interventions

DRUGIDX184

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

DRUGPlacebo

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

BIOLOGICALPeginterferon 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.

DRUGRibavirin (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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in ALT level from Baseline to Day 28	Baseline and Day 28
Maximum concentration (Cmax)	Up to 28 days
Time to maximum concentration (Tmax)	Up to 28 days
Change in HCV RNA level from Baseline to Day 28	Baseline and Day 28
AUC from time zero to infinity (AUC0-~)	Up to 28 days
Trough concentration (Ctrough)	Up to 28 days
Observed terminal half-life (Thalf)	Up to 28 days
Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)	Up to 28 days
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

Outcome results

None listed

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