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Trial record 50 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601573
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : November 13, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Grazoprevir Drug: Elbasvir Drug: Ribavirin Drug: Sofosbuvir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 5, 2016
Actual Primary Completion Date : October 18, 2016
Actual Study Completion Date : January 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
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.
Drug: Grazoprevir
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.
Other Name: MK-5172

Drug: Elbasvir
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.
Other Name: MK-8742

Drug: Ribavirin
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).
Other Name: Rebetol®

Drug: Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Other Name: Sovaldi®, Harvoni®

Experimental: Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
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.
Drug: Grazoprevir
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.
Other Name: MK-5172

Drug: Elbasvir
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.
Other Name: MK-8742

Drug: Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Other Name: Sovaldi®, Harvoni®

Experimental: Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
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.
Drug: Grazoprevir
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.
Other Name: MK-5172

Drug: Elbasvir
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.
Other Name: MK-8742

Drug: Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Other Name: Sovaldi®, Harvoni®

Experimental: Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
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.
Drug: Grazoprevir
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.
Other Name: MK-5172

Drug: Elbasvir
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.
Other Name: MK-8742

Drug: Ribavirin
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).
Other Name: Rebetol®

Drug: Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Other Name: Sovaldi®, Harvoni®

Experimental: Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
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.
Drug: Grazoprevir
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.
Other Name: MK-5172

Drug: Elbasvir
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.
Other Name: MK-8742

Drug: Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Other Name: Sovaldi®, Harvoni®




Primary Outcome Measures :
  1. Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy) [ Time Frame: Up to Week 28 ]
    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.

  2. Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 18 weeks (up to 2 weeks after completion of study treatment) ]
    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.

  3. Percentage of Participants Discontinuing From Study Therapy Due to an AE [ Time Frame: Up to 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy) [ Time Frame: Up to Week 40 ]
    The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601573


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02601573    
Other Study ID Numbers: 5172-083
2015-003187-37 ( EudraCT Number )
MK-5172-083 ( Other Identifier: Merck Protocol Number )
First Posted: November 10, 2015    Key Record Dates
Results First Posted: November 13, 2017
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents