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

NCT02252016 | Completed Phase 3 Results DMC

• 2 other identifiers: 5172-0652014-002356-27
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)

  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.

  12 weeks after completing study therapy (Week 24)

• Percentage of Participants Experiencing an Adverse Event (AE)

  An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.

  Up to Week 14

• Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)

  An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.

  Up to Week 12

Secondary Outcomes (1)

• Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)

  24 weeks after completing study therapy (Week 36)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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.

Drug: Grazoprevir + Elbasvir

Deferred Treatment

PLACEBO COMPARATOR

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.

Drug: Grazoprevir + Elbasvir; Drug: Placebo

Interventions

Grazoprevir + Elbasvir DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

Deferred Treatment; Immediate Treatment

Placebo DRUG

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Deferred Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Hezode C, Colombo M, Bourliere M, Spengler U, Ben-Ari Z, Strasser SI, Lee WM, Morgan L, Qiu J, Hwang P, Robertson M, Nguyen BY, Barr E, Wahl J, Haber B, Chase R, Talwani R, Marco VD; C-EDGE IBLD Study Investigators. Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. Hepatology. 2017 Sep;66(3):736-745. doi: 10.1002/hep.29139. Epub 2017 Jul 20.

  PMID: 28256747 RESULT

• Asselah T, Reesink H, Gerstoft J, de Ledinghen V, Pockros PJ, Robertson M, Hwang P, Asante-Appiah E, Wahl J, Nguyen BY, Barr E, Talwani R, Serfaty L. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018 Sep;38(9):1583-1591. doi: 10.1111/liv.13727. Epub 2018 Mar 31.

  PMID: 29461687 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Glocal Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: October 22, 2014
• Primary Completion: December 7, 2015
• Study Completion: June 14, 2016
• Last Updated: October 3, 2018
• Results First Posted: January 19, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share