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Clinical Trials

MainTitle

Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT02252016

First received: September 25, 2014
Last updated: May 25, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

Condition Intervention Phase
Hepatitis C

Drug : Grazoprevir + Elbasvir
Drug : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) [ Time Frame: 12 weeks after completing study therapy (Week 24) ]
    The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
  • Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Week 14 ]
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
  • Percentage of Participants Discontinuing From Study Treatment Due to an AE(s) [ Time Frame: Up to Week 12 ]
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
Secondary Outcome Measures:
  • Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) [ Time Frame: 24 weeks after completing study therapy (Week 36) ]
    The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.

Enrollment: 159
Study Start Date: October 22, 2014
Study Completion Date: June 14, 2016
Primary Completion Date: December 7, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Immediate Treatment
Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.
Drug: Grazoprevir + Elbasvir

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Placebo Comparator: Deferred Treatment
Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.
Drug: Grazoprevir + Elbasvir

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Drug: Placebo

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
  • has cirrhosis or is non-cirrhotic
  • is human immunodeficiency virus (HIV) coinfected or not infected with HIV
  • is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception


Exclusion Criteria:
  • has evidence of decompensated liver disease
  • is coinfected with hepatitis B
  • has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • has hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • has clinically-relevant drug or alcohol abuse within 12 months of screening

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02252016

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT02252016   History of Changes  
Other Study ID Numbers: 5172-065  
  2014-002356-27  
Study First Received: September 25, 2014  
Last Updated: May 25, 2017  
Individual Participant Data    
Plan to Share IPD: Yes  

Additional relevant MeSH terms:
Hepatitis
Hepatitis C

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.