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Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) (C-SURFER)

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ClinicalTrials.gov Identifier: NCT02092350
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : April 12, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 17, 2014
First Posted Date  ICMJE March 20, 2014
Results First Submitted Date  ICMJE February 3, 2016
Results First Posted Date  ICMJE April 12, 2016
Last Update Posted Date September 24, 2018
Actual Study Start Date  ICMJE March 17, 2014
Actual Primary Completion Date March 11, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) [ Time Frame: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment) ]
    SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
  • Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods [ Time Frame: Up to Week 14 ]
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
  • Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period [ Time Frame: Up to Week 12 ]
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • Number of participants achieving sustained viral response 12 weeks after the end of all treatment (SVR12) [ Time Frame: Up to 28 weeks, depending on arm assignment ]
  • Number of participants experiencing adverse events [ Time Frame: Up to 52 weeks, depending on arm assignment ]
  • Number of participants discontinuing study drug due to AEs [ Time Frame: Up to 28 weeks, depending on arm assignment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) [ Time Frame: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment) ]
    SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
  • Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4) [ Time Frame: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment) ]
    SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
  • Number of participants experiencing SVR 4 weeks after the end of all treatment (SVR4) [ Time Frame: Up to 32 weeks, depending on arm assignment ]
  • Number of participants experiencing SVR 24 weeks after the end of all treatment (SVR24) [ Time Frame: Up to Week 52, depending on arm assignment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Official Title  ICMJE A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
Brief Summary This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus
Intervention  ICMJE
  • Drug: Grazoprevir
    Grazoprevir 100 mg tablet
    Other Name: MK-5172
  • Drug: Elbasvir
    Elbasvir 50 mg tablet
    Other Name: MK-8742
  • Drug: Placebo to Grazoprevir
    Placebo tablet matched to grazoprevir
  • Drug: Placebo to Elbasvir
    Placebo tablet matched to elbasvir
Study Arms  ICMJE
  • Experimental: Immediate Treatment
    Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Elbasvir
  • Experimental: Deferred Treatment
    Participants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Elbasvir
    • Drug: Placebo to Grazoprevir
    • Drug: Placebo to Elbasvir
  • Experimental: Intensive PK
    Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.
    Interventions:
    • Drug: Grazoprevir
    • Drug: Elbasvir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2015)
237
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
220
Actual Study Completion Date  ICMJE September 2, 2015
Actual Primary Completion Date March 11, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
  • Evidence or no evidence of liver cirrhosis based on one of the following:
  • Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
  • Fibroscan performed within 12 months of Day 1 of this study
  • Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period)
  • Has HCV status that is one of the following:
  • Treatment naïve
  • Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
  • Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
  • Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
  • Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • On peritoneal dialysis for management of kidney disease
  • Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
  • History of malignancy <=5 years prior to signing informed consent
  • Clinical diagnosis of substance abuse
  • Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations
  • Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
  • Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  • Uncontrolled or poorly controlled hypertension
  • Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
  • New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
  • Severe active peripheral vascular disease
  • Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
  • Evidence or history of chronic hepatitis not caused by HCV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Canada,   Estonia,   France,   Israel,   Korea, Republic of,   Lithuania,   Netherlands,   Spain,   Sweden,   United States
 
Administrative Information
NCT Number  ICMJE NCT02092350
Other Study ID Numbers  ICMJE 5172-052
2013-003858-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP