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Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

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ClinicalTrials.gov Identifier: NCT02133131
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : November 17, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Grazoprevir/Elbasvir FDC Drug: Sofosbuvir Phase 2

Detailed Description:
The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination [FDC] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection
Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: GT1:NC Grazoprevir/Elbasvir+SOF 4wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT1:NC Grazoprevir/Elbasvir+SOF 6wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT1:C Grazoprevir/Elbasvir+SOF 6wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT1:C Grazoprevir/Elbasvir+SOF 8wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT3:NC Grazoprevir/Elbasvir+SOF 8wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT3:NC Grazoprevir/Elbasvir+SOF 12wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

Experimental: GT3:C Grazoprevir/Elbasvir+SOF 12wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Name: MK-5172A, Zepatier

Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12) [ Time Frame: Up to 24 weeks ]
    The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.

  2. Number of Participants Experiencing at Least 1 Adverse Event (AE) [ 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.

  3. Number of Participants Discontinuing Study Therapy Due to an AE [ 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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4) [ Time Frame: Up to 16 weeks ]
    The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.



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:

  • has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
  • has documented chronic HCV GT1 or GT3 infection
  • has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
  • is treatment naïve to all anti-HCV treatment

Exclusion Criteria:

  • has evidence of decompensated liver disease
  • is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
  • has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
  • has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • has clinically-relevant drug or alcohol abuse within 12 months of screening
  • has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  • has a 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): NCT02133131


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02133131     History of Changes
Other Study ID Numbers: 5172-074
First Posted: May 7, 2014    Key Record Dates
Results First Posted: November 17, 2016
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents