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Trial record 26 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

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ClinicalTrials.gov Identifier: NCT02252016
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : January 19, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 25, 2014
First Posted Date  ICMJE September 29, 2014
Results First Submitted Date  ICMJE November 22, 2016
Results First Posted Date  ICMJE January 19, 2017
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE October 22, 2014
Actual Primary Completion Date December 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Proportion of participants achieving SVR12 [ Time Frame: Week 24 ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Week 52 ]
  • Number of participants discontinuing from study treatment due to AEs [ Time Frame: Up to Week 12 ]
Change History Complete list of historical versions of study NCT02252016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Proportion of subjects achieving SVR24 [ Time Frame: Week 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
Official Title  ICMJE 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
Brief Summary 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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Grazoprevir + Elbasvir
  • 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.
    Interventions:
    • Drug: Grazoprevir + Elbasvir
    • Drug: Placebo
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: July 2, 2015)
159
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2014)
200
Actual Study Completion Date  ICMJE June 14, 2016
Actual Primary Completion Date December 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Australia,   Canada,   France,   Germany,   Greece,   Israel,   Italy,   Thailand,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT02252016
Other Study ID Numbers  ICMJE 5172-065
2014-002356-27 ( 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 September 2018

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