- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01371604
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
February 5, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
IDX184 50 mg tablet administered orally
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
Other Names:
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.
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.
|
IDX184 50 mg tablet administered orally
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants who experience a serious adverse event
Time Frame: Up to Week 16 and end of treatment (Weeks 24 or 48)
|
Up to Week 16 and end of treatment (Weeks 24 or 48)
|
Percentage of participants who experience an adverse event
Time Frame: 16 weeks
|
16 weeks
|
Percentage of participants who experience a grade 1-4 laboratory abnormality
Time Frame: 16 weeks
|
16 weeks
|
Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
Time Frame: Week 12
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
Time Frame: Week 4
|
Week 4
|
Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
Time Frame: Weeks 24 or 48
|
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)
|
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
|
Week 4
|
Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
Time Frame: Weeks 24 or 48
|
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
|
Weeks 48 or 72
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
June 9, 2011
First Submitted That Met QC Criteria
June 10, 2011
First Posted (Estimate)
June 13, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- 2355-005
- IDX-08C-005 (Other Identifier: Idenix Protocol Number)
- 2011-001878-25 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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