Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection
3 other identifiers
interventional
101
0 countries
N/A
Brief Summary
This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedStudy Start
First participant enrolled
January 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2017
CompletedResults Posted
Study results publicly available
November 13, 2017
CompletedAugust 13, 2019
August 1, 2019
10 months
November 9, 2015
October 12, 2017
August 5, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)
The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Up to Week 28
Percentage of Participants Experiencing an Adverse Event (AE)
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.
Up to 18 weeks (up to 2 weeks after completion of study treatment)
Percentage of Participants Discontinuing From Study Therapy Due to an AE
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.
Up to 16 weeks
Secondary Outcomes (1)
Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
Up to Week 40
Study Arms (5)
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
EXPERIMENTALTN HCV GT3 participants will take 1 fixed-dose combination (FDC) tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg once-daily (q.d.) with RBV (200 mg capsules; weight-based dosing) twice-daily (b.i.d.) for 8 weeks.
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
EXPERIMENTALTN HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
EXPERIMENTALTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
EXPERIMENTALTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
EXPERIMENTALTE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Interventions
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Eligibility Criteria
You may qualify if:
- has HCV RNA (\>= 10,000 IU/mL in peripheral blood) at screening
- has documented HCV GT3 (with no evidence of non-typeable or mixed GT infection)
- has compensated cirrhosis of the liver
- has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC)
- is either HCV TN or TE (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin)
- is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements
- has compensated cirrhosis of the liver
- is TN or TE (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin)
- is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations)
You may not qualify if:
- has previously received one or more doses of a direct-acting antiviral (DAA)
- has evidence of decompensated liver disease
- is coinfected with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive)
- has a recent (within 5 years) history of malignancy or is under evaluation for HCC or other suspected malignancy
- is currently or has participated (within past 30 days) in a study with an investigational compound
- has clinically-relevant drug or alcohol abuse within the past 12 months of screening
- is a female and is pregnant or breast-feeding
- is a male whose female partner is/are pregnant
- has any of the following:
- organ transplants
- poor venous access
- history of gastric surgery or malabsorption disorder
- current or history of clinically significant cardiac abnormalities or dysfunction
- chronic pulmonary disease
- hemoglobinopathy
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Foster GR, Agarwal K, Cramp ME, Moreea S, Barclay S, Collier J, Brown AS, Ryder SD, Ustianowski A, Forton DM, Fox R, Gordon F, Rosenberg WM, Mutimer DJ, Du J, Gilbert CL, Asante-Appiah E, Wahl J, Robertson MN, Barr E, Haber B. Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial. Hepatology. 2018 Jun;67(6):2113-2126. doi: 10.1002/hep.29852. Epub 2018 Apr 19.
PMID: 29473975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 10, 2015
Study Start
January 5, 2016
Primary Completion
October 18, 2016
Study Completion
January 6, 2017
Last Updated
August 13, 2019
Results First Posted
November 13, 2017
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf