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

Chronic Hepatitis C Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011166
• Other study ID #: 2355-004
• Secondary ID: IDX-08C-004
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2009
• Last updated: April 22, 2015
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
• Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.

Biological:
• Peginterferon 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.

Drug:
• Ribavirin (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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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-Bólyai J, Mayers D. IDX184 in combination with pegylated interferon-a2a and rib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15		Baseline and Day 15	No
Primary	Percentage of participants experiencing adverse events (AEs)		Up to 28 days	Yes
Primary	Percentage of participants experiencing serious adverse events (SAEs)		Up to 28 days	Yes
Primary	Percentage of participants experiencing dose-limiting toxicities (DLTs)		Up to 28 days	Yes
Primary	Percentage of participants experiencing Grade 1-4 laboratory abnormalities		Up to 28 days	Yes
Secondary	Change in HCV RNA level from Baseline to Day 28		Baseline and Day 28	No
Secondary	Percentage of participants with undetectable HCV RNA at Day 15		Day 15	No
Secondary	Percentage of participants with undetectable HCV RNA at Day 28		Day 28	No
Secondary	Percentage of participants experiencing virologic breakthrough while on study therapy		Up to 28 days	No
Secondary	Change in alanine aminotransferase (ALT) level from Baseline to Day 15		Baseline and Day 15	No
Secondary	Change in ALT level from Baseline to Day 28		Baseline and Day 28	No
Secondary	Maximum concentration (Cmax)		Up to 28 days	No
Secondary	Time to maximum concentration (Tmax)		Up to 28 days	No
Secondary	Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)		Up to 28 days	No
Secondary	AUC from time zero to infinity (AUC0-~)		Up to 28 days	No
Secondary	Trough concentration (Ctrough)		Up to 28 days	No
Secondary	Observed terminal half-life (Thalf)		Up to 28 days	No