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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01371604
First received: June 9, 2011
Last updated: February 5, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: IDX184
Biological: Peginterferon alfa-2a (Peg-IFN)
Drug: Ribavirin (RBV)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants who experience a serious adverse event [ Time Frame: Up to Week 16 and end of treatment (Weeks 24 or 48) ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience an adverse event [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience a grade 1-4 laboratory abnormality [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment [ Time Frame: Weeks 24 or 48 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve sustained virologic response (SVR) [ Time Frame: 24 weeks after the last dose (Weeks 48 or 72) ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment [ Time Frame: Weeks 24 or 48 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose) [ Time Frame: Weeks 48 or 72 ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2011
Study Completion Date: October 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDX184 50 mg + Peg-IFN/RBV
IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.
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
Other Name: Pegasys
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.
Drug: Placebo
Matching placebo to IDX184 50 mg tablet administered orally
Experimental: IDX184 100 mg + Peg-IFN/RBV
IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.
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
Other Name: Pegasys
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371604

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01371604     History of Changes
Other Study ID Numbers: 2355-005, IDX-08C-005, 2011-001878-25
Study First Received: June 9, 2011
Last Updated: February 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis C
HCV
treatment-naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 02, 2015