Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)
NCT ID: NCT01353911
Last Updated: 2024-05-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
368 participants
INTERVENTIONAL
2011-06-27
2015-03-10
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.
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
NCT01440595
A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)
NCT01710501
A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)
NCT01716156
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)
NCT02105701
A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
NCT01717326
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Amendment 5 allowed treatment-naïve participants with chronic hepatitis C and compensated cirrhosis to be enrolled and receive open-label grazoprevir 100 mg in combination with Peg-IFN and RBV, without a corresponding control arm.
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
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Grazoprevir 100 mg
TN non-cirrhotic (NC) participants receive Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Placebo for Boceprevir
Four capsules orally three times daily.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Grazoprevir 200 mg
TN NC participants receive Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Placebo for Boceprevir
Four capsules orally three times daily.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Grazoprevir 400 mg
TN NC participants receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Placebo for Boceprevir
Four capsules orally three times daily.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Grazoprevir 800 mg
TN NC participants receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Placebo for Boceprevir
Four capsules orally three times daily.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Boceprevir 800 mg
TN NC participants start a 4 week lead-in with Peg-IFN + RBV, then receive Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
Boceprevir
Four 200 mg capsules orally three times daily.
Placebo for Grazoprevir
Orally once daily in AM.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Grazoprevir 400 mg/100 mg
As the result of an interim analysis, TN NC participants assigned to the 400 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Grazoprevir 800 mg/100 mg
As the result of an interim analysis, TN NC participants assigned to the 800 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
OL Grazoprevir 100 mg
TN cirrhotic participants receive open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Grazoprevir
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Boceprevir
Four 200 mg capsules orally three times daily.
Placebo for Grazoprevir
Orally once daily in AM.
Placebo for Boceprevir
Four capsules orally three times daily.
Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection.
Ribavirin
300 mg to 700 mg orally twice daily.
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
* Has hepatitis C virus (HCV) ribonucleic acid (RNA value) ≥10,000 IU/mL
* Body weight ≥40 kg (88 lbs) and ≤125 kg (275 lbs)
* Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver disease
* Had a liver biopsy within 3 years of screening or between screening and Day 1 with histology consistent with CHC and no evidence of cirrhosis or hepatocellular carcinoma or no other cause for chronic liver disease (for participants with compensated cirrhosis, any liver biopsy demonstrating cirrhosis regardless of length of time since biopsy)
* Female of childbearing potential or a male with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
* For participants with compensated cirrhosis, evidence of cirrhosis without evidence of hepatocellular carcinoma (confirmed by ultrasound within 4 weeks prior)
Exclusion Criteria
* Is human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
* Has received prior approved or investigational treatment for hepatitis C
* Has evidence of hepatocellular carcinoma or is under evaluation for hepatocellular carcinoma
* For participants with compensated cirrhosis: alphafetoprotein level of ≥100 ng/mL
* Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
* Has evidence or history of chronic hepatitis not caused by HCV
* Is diabetic and/or hypertensive with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
* Has any known medical condition that could interfere with participation in and completion of the study
* Pre-existing psychiatric condition including but not limited to moderate or severe depression, suicidal or homicidal ideation or attempt, schizophrenia, psychosis, bipolar disorder, post traumatic stress disorder, or mania
* Is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
* Member or family member of study staff
18 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.
Manns MP, Vierling JM, Bacon BR, Bruno S, Shibolet O, Baruch Y, Marcellin P, Caro L, Howe AY, Fandozzi C, Gress J, Gilbert CL, Shaw PM, Cooreman MP, Robertson MN, Hwang P, Dutko FJ, Wahl J, Mobashery N. The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis. Gastroenterology. 2014 Aug;147(2):366-76.e6. doi: 10.1053/j.gastro.2014.04.006. Epub 2014 Apr 12.
Howe AY, Black S, Curry S, Ludmerer SW, Liu R, Barnard RJ, Newhard W, Hwang PM, Nickle D, Gilbert C, Caro L, DiNubile MJ, Mobashery N. Virologic resistance analysis from a phase 2 study of MK-5172 combined with pegylated interferon/ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Clin Infect Dis. 2014 Dec 15;59(12):1657-65. doi: 10.1093/cid/ciu696. Epub 2014 Sep 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-000759-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5172-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.