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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.

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%.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Grazoprevir Drug: Elbasvir Drug: Placebo to Grazoprevir Drug: Placebo to Elbasvir Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 17, 2014
Actual Primary Completion Date : March 11, 2015
Actual Study Completion Date : September 2, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Treatment
Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks.
Drug: Grazoprevir
Grazoprevir 100 mg tablet
Other Name: MK-5172

Drug: Elbasvir
Elbasvir 50 mg tablet
Other Name: MK-8742

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.
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

Experimental: Intensive PK
Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.
Drug: Grazoprevir
Grazoprevir 100 mg tablet
Other Name: MK-5172

Drug: Elbasvir
Elbasvir 50 mg tablet
Other Name: MK-8742




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092350


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02092350     History of Changes
Other Study ID Numbers: 5172-052
2013-003858-25 ( EudraCT Number )
First Posted: March 20, 2014    Key Record Dates
Results First Posted: April 12, 2016
Last Update Posted: September 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency
Hepatitis, Chronic
MK-5172
Antiviral Agents
Anti-Infective Agents