Clinical trial NCT01011166: Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C
HepC
Hep C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Percentage of participants experiencing adverse events (AEs)
timeFrame: Up to 28 days
measure: Percentage of participants experiencing serious adverse events (SAEs)
timeFrame: Up to 28 days
measure: Percentage of participants experiencing dose-limiting toxicities (DLTs)
timeFrame: Up to 28 days
measure: Percentage of participants experiencing Grade 1-4 laboratory abnormalities
timeFrame: Up to 28 days
Secondary outcomes:
measure: Change in HCV RNA level from Baseline to Day 28
timeFrame: Baseline and Day 28
measure: Percentage of participants with undetectable HCV RNA at Day 15
timeFrame: Day 15
measure: Percentage of participants with undetectable HCV RNA at Day 28
timeFrame: Day 28
measure: Percentage of participants experiencing virologic breakthrough while on study therapy
timeFrame: Up to 28 days
measure: Change in alanine aminotransferase (ALT) level from Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in ALT level from Baseline to Day 28
timeFrame: Baseline and Day 28
measure: Maximum concentration (Cmax)
timeFrame: Up to 28 days
measure: Time to maximum concentration (Tmax)
timeFrame: Up to 28 days
measure: Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)
timeFrame: Up to 28 days
measure: AUC from time zero to infinity (AUC0-~)
timeFrame: Up to 28 days
measure: Trough concentration (Ctrough)
timeFrame: Up to 28 days
measure: Observed terminal half-life (Thalf)
timeFrame: Up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.