Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments grazoprevir, elbasvir, ribavirin, sofosbuvir
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Start date January 2016
End date October 2016
Trial size 125 participants
Trial identifier NCT02601573, 2015-003187-37, 5172-083

Summary

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of elbasvir (50 mg)/grazoprevir (100 mg) (EBR/GZR) and 400 mg of sofosbuvir (SOF), with and without ribavirin (RBV), in treatment-naïve (TN) and treatment-experienced (TE) subjects with chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) infection with compensated cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TN 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.
grazoprevir MK-5172A
GZR 100 mg provided in a FDC tablet also containing EBR 50 mg (MK-5172A) taken q.d. by mouth in the morning.
elbasvir MK-5172A
EBR 50 mg provided in a FDC tablet also containing GZR 100 mg (MK-5172A) taken q.d. by mouth in the morning.
ribavirin Rebetol®
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose of 800 mg to 1400 mg based on participant body weight.
sofosbuvir Sovaldi®, Harvoni®
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
(Experimental)
TN 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.
grazoprevir MK-5172A
GZR 100 mg provided in a FDC tablet also containing EBR 50 mg (MK-5172A) taken q.d. by mouth in the morning.
elbasvir MK-5172A
EBR 50 mg provided in a FDC tablet also containing GZR 100 mg (MK-5172A) taken q.d. by mouth in the morning.
sofosbuvir Sovaldi®, Harvoni®
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
(Experimental)
TE 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.
grazoprevir MK-5172A
GZR 100 mg provided in a FDC tablet also containing EBR 50 mg (MK-5172A) taken q.d. by mouth in the morning.
elbasvir MK-5172A
EBR 50 mg provided in a FDC tablet also containing GZR 100 mg (MK-5172A) taken q.d. by mouth in the morning.
sofosbuvir Sovaldi®, Harvoni®
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
(Experimental)
TE 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.
grazoprevir MK-5172A
GZR 100 mg provided in a FDC tablet also containing EBR 50 mg (MK-5172A) taken q.d. by mouth in the morning.
elbasvir MK-5172A
EBR 50 mg provided in a FDC tablet also containing GZR 100 mg (MK-5172A) taken q.d. by mouth in the morning.
ribavirin Rebetol®
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose of 800 mg to 1400 mg based on participant body weight.
sofosbuvir Sovaldi®, Harvoni®
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
(Experimental)
TE 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.
grazoprevir MK-5172A
GZR 100 mg provided in a FDC tablet also containing EBR 50 mg (MK-5172A) taken q.d. by mouth in the morning.
elbasvir MK-5172A
EBR 50 mg provided in a FDC tablet also containing GZR 100 mg (MK-5172A) taken q.d. by mouth in the morning.
sofosbuvir Sovaldi®, Harvoni®
SOF 400 mg tablet taken q.d. by mouth in the morning with food.

Primary Outcomes

Measure
Percentage of participants achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy)
time frame: Up to 28 weeks
Number of participants experiencing an adverse event (AE)
time frame: Up to 18 weeks
Number of participants discontinuing from study therapy due to an AE
time frame: Up to 16 weeks

Secondary Outcomes

Measure
Percentage of participants achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy)
time frame: Up to 40 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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 - history of hospitalization within 3 months prior to enrollment - medical or surgical condition that may result in need for hospitalization during the course of the study - any condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppresant drugs during the course of the study - any condition, prestudy laboratory or ECG abnormality, or history of any illness, which could confound results of the study or pose additional risks in administering study drugs in the opinion of the investigator - has a life-threatening serious AE (SAE) during the screening period - has evidence of history of chronic hepatitis not caused by HCV

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..