Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
NCT ID: NCT01011166
Last Updated: 2015-04-23
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2009-11-30
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
NCT01371604
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects
NCT00807001
Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)
NCT00237484
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
NCT01903954
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
NCT00192647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Ribavirin (RBV)
RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy
Exclusion Criteria
* Has cirrhosis or decompensated liver disease
* Is pregnant or breastfeeding
* Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV)
* Has clinically significant concomitant disease
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDX-08C-004
Identifier Type: OTHER
Identifier Source: secondary_id
2355-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.