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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:
ClinicalTrials.gov Identifier:
NCT01371604
First Posted: June 13, 2011
Last Update Posted: February 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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) ]
  • Percentage of participants who experience an adverse event [ Time Frame: 16 weeks ]
  • Percentage of participants who experience a grade 1-4 laboratory abnormality [ Time Frame: 16 weeks ]
  • Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4 [ Time Frame: Week 4 ]
  • Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment [ Time Frame: Weeks 24 or 48 ]
  • Percentage of participants who achieve sustained virologic response (SVR) [ Time Frame: 24 weeks after the last dose (Weeks 48 or 72) ]
  • Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4 [ Time Frame: Week 4 ]
  • Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment [ Time Frame: Weeks 24 or 48 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371604


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01371604     History of Changes
Other Study ID Numbers: 2355-005
IDX-08C-005 ( Other Identifier: Idenix Protocol Number )
2011-001878-25 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Last Update Posted: February 6, 2015
Last Verified: February 2015

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

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