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Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)

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ClinicalTrials.gov Identifier: NCT02105454
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : March 4, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: Grazoprevir (GZR)
Drug: Elbasvir (EBR)
Drug: Ribavirin (RBV)
Enrollment 79
Recruitment Details  
Pre-assignment Details Following 12 weeks of treatment with grazoprevir (GZR), elbasvir (EBR) and ribavirin (RBV), participants were followed-up for an additional 24 weeks.
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Period Title: Overall Study
Started 79
Completed 78
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants
54.4  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
33
  41.8%
Male
46
  58.2%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)
Hide Description SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description:
Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.1
(90.1 to 99.7)
2.Primary Outcome
Title Percentage of Participants Experiencing Adverse Events
Hide Description Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Time Frame Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population defined as all participants who received at least one dose of study medication.
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description:
Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: Percentage of participants
79.7
3.Primary Outcome
Title Percentage of Participants Discontinuing Study Drug Due to an Adverse Event
Hide Description Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population defined as all participants who received at least one dose of study medication.
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description:
Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: Percentage of participants
1.3
4.Secondary Outcome
Title Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy
Hide Description SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description:
Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Boceprevir with signature baseline RAVs, n=9
88.9
(51.8 to 99.7)
Boceprevir without signature baseline RAVs, n=16
100.0
(79.4 to 100.0)
Telaprevir with signature baseline RAVs, n=18
94.4
(72.7 to 99.9)
Telaprevir without signature baseline RAVs, n=22
100.0
(84.6 to 100.0)
Simeprevir with signature baseline RAVs, n=4
100.0
(39.8 to 100.0)
Simeprevir without signature baseline RAVs, n=1
100.0
(2.5 to 100.0)
Time Frame Serious adverse events (SAEs): up to 40 weeks (including 24-week follow-up [-12/+4 weeks]); non-serious adverse events (NSAEs): Up to 14 weeks (including 2-week follow-up)
Adverse Event Reporting Description All participants as treated population included all participants who received at least 1 dose of study medication. MedDRA version 17.1: AEs summarized in the 1st Clinical Study Report (CSR) (through at least 12 weeks of follow-up); MedDRA version 18.0: AEs summarized in the final CSR after study completion (through 24 weeks of follow-up).
 
Arm/Group Title GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Hide Arm/Group Description Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
All-Cause Mortality
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Affected / at Risk (%) # Events
Total   6/79 (7.59%)    
Gastrointestinal disorders   
Inguinal hernia  1  1/79 (1.27%)  1
Infections and infestations   
Appendicitis  1  1/79 (1.27%)  1
Pharyngitis bacterial  1  1/79 (1.27%)  1
Urinary tract infection  1  1/79 (1.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Laryngeal squamous cell carcinoma  1  1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/79 (1.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1, 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks
Affected / at Risk (%) # Events
Total   47/79 (59.49%)    
Blood and lymphatic system disorders   
Anaemia  1  6/79 (7.59%)  6
Gastrointestinal disorders   
Abdominal pain upper  1  5/79 (6.33%)  5
Constipation  1  5/79 (6.33%)  5
Diarrhoea  1  6/79 (7.59%)  11
Nausea  1  9/79 (11.39%)  10
Vomiting  1  4/79 (5.06%)  4
General disorders   
Asthenia  1  12/79 (15.19%)  12
Fatigue  1  22/79 (27.85%)  24
Investigations   
Haemoglobin decreased  1  4/79 (5.06%)  4
Nervous system disorders   
Headache  1  15/79 (18.99%)  16
Psychiatric disorders   
Insomnia  1  7/79 (8.86%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1, 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02105454     History of Changes
Other Study ID Numbers: 5172-048
2013-004213-41 ( EudraCT Number )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: September 24, 2018