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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371604
• Other study ID #: 2355-005
• Secondary ID: IDX-08C-0052011-
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2011
• Last updated: February 5, 2015
• Start date: July 2011
• Est. completion date: October 2014

Study information

• Verified date: February 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• IDX184
IDX184 50 mg tablet administered orally

Biological:
• Peginterferon alfa-2a (Peg-IFN)
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly

Drug:
• Ribavirin (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.
• Placebo
Matching placebo to IDX184 50 mg tablet administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who experience a serious adverse event		Up to Week 16 and end of treatment (Weeks 24 or 48)	Yes
Primary	Percentage of participants who experience an adverse event		16 weeks	Yes
Primary	Percentage of participants who experience a grade 1-4 laboratory abnormality		16 weeks	Yes
Primary	Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12		Week 12	No
Secondary	Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4		Week 4	No
Secondary	Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment		Weeks 24 or 48	No
Secondary	Percentage of participants who achieve sustained virologic response (SVR)		24 weeks after the last dose (Weeks 48 or 72)	No
Secondary	Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4		Week 4	No
Secondary	Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment		Weeks 24 or 48	No
Secondary	Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)		Weeks 48 or 72	No