Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
NCT ID: NCT01371604
Last Updated: 2015-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2011-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
IDX184 50 mg tablet administered orally
Peginterferon alfa-2a (Peg-IFN)
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
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
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
IDX184 50 mg tablet administered orally
Peginterferon alfa-2a (Peg-IFN)
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
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.
Interventions
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IDX184
IDX184 50 mg tablet administered orally
Peginterferon alfa-2a (Peg-IFN)
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV).
18 Years
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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IDX-08C-005
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001878-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2355-005
Identifier Type: -
Identifier Source: org_study_id
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