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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Ribavirin (RBV); Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: IDX184

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011166

2355-004

IDX-08C-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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81 participants in 6 patient groups

IDX184 50 mg QD + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)

IDX184 100 mg QD + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)

IDX184 100 mg BID + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)

IDX184 150 mg QD + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)

IDX184 200 mg QD + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)

IDX184 200 mg BID + Peg-IFN/RBV

Experimental group

Description:

Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

Treatment:

Drug: IDX184

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: Placebo

Drug: Ribavirin (RBV)