Clinical Trials

MainTitle

Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)

This study has been withdrawn
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT03143998

First received: May 4, 2017
Last updated: November 7, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).

Condition Intervention Phase
Hepatitis C

Drug : MK-5172A
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Site, Open-Label, Trial of the Efficacy and Safety of Fixed-dose Elbasvir/Grazoprevir (EBR/GZR) in Brazilian Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Percentage of participants achieving sustained virologic response (SVR) 12 weeks after the end of all study therapy (SVR12) [ Time Frame: Week 24 (12 weeks after completing study therapy) ]
    SVR12 will be declared when a participant has HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
  • Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to 14 weeks ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
  • Percentage of participants withdrawing from study therapy due to an AE [ Time Frame: Up to 12 weeks ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Secondary Outcome Measures:
  • Percentage of participants achieving SVR 24 weeks after the end of all study therapy (SVR24) [ Time Frame: Week 36 (24 weeks after completing study therapy) ]
    SVR24 will be declared when a participant has HCV RNA < LLOQ 24 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
  • Emergence of viral resistance-associated variants (RAVs) [ Time Frame: Up to 12 weeks ]
    The RAVs resistant to EBR or GZR, including the association of baseline RAVs with treatment outcomes (SVR12 and SVR24) and the emergence of RAVs in participants who fail to achieve SVR will be determined.

Enrollment: 0
Anticipated Study Start Date: February 12, 2018
Estimated Study Completion Date: January 12, 2019
Estimated Primary Completion Date: January 12, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: HCV GT1a TN
Participants with HCV GT1a infection who are TN will take MK-5172A for 12 weeks.
Drug: MK-5172A

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

Other Name: ZEPATIER®
Experimental: HCV GT1a TE
Participants with HCV GT1a infection who are TE will take MK-5172A for 12 weeks.
Drug: MK-5172A

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

Other Name: ZEPATIER®
Experimental: HCV GT1b TN
Participants with HCV GT1b infection who are TN will take MK-5172A for 12 weeks.
Drug: MK-5172A

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

Other Name: ZEPATIER®
Experimental: HCV GT1b TE
Participants with HCV GT1b infection who are TE will take MK-5172A for 12 weeks.
Drug: MK-5172A

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

Other Name: ZEPATIER®
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Adult (≥ 18 years of age) male and female participants with chronic HCV GT1 infection who reside in Brazil
  • HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
  • Has documented chronic HCV GT1 (1a; 1b) infection (with no evidence of non-typeable or mixed genotype) infection.
    • positive for anti HCV antibody, HCV RNA, or HCV GT1 at least 6 months before screening, or
    • positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C (CHC) disease, such as the presence of fibrosis)
  • Is otherwise healthy as determined by the medical history, physical examination, and clinical laboratory measurements at the time of screening
  • Has a history of advanced fibrosis (F3 or F4) as follows:
    • F4: FibroSure®/APRI + FibroTest®
    • Liver biopsy result of METAVIR stage 3 or 4 fibrosis (or its grading system equivalency to advanced fibrosis)
    • FibroScan® result > 9.5 kPa (F3 or F4)
  • Has liver imaging within 6 months of Day 1 (start of treatment) with no evidence of hepatocellular carcinoma (HCC)
  • Is TN or TE
  • Is a male, is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant from Day 1 (start of treatment) through 14 days after the last dose of study drug (or longer if dictated by local regulations)
  • For HIV-infected participants, has HIV-1 infection documented prior to screening, and is either not currently on antiretroviral therapy (ART) and has no plans to initiate ART or has well-controlled HIV on ART as per study criteria


Exclusion Criteria:
  • Has prior treatment with direct acting antiviral (DAA) therapy with the exception of boceprevir, telaprevir, and simeprevir
  • Has evidence of decompensated liver disease as manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
  • Is classified as Child-Pugh B or C or has a Child-Pugh-Turcotte score > 6
  • Is hepatitis B surface antigen (HBsAg) positive at screening
  • Is under evaluation for HCC or other active or suspected malignancy
  • Is currently participating or has participated in a study with an investigational compound within 1 year of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
  • Has clinically-relevant drug or alcohol abuse within 12 months of screening
  • Is a female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from Day 1 (start of treatment) through 14 days after the last dose of study drug or longer if dictated by local regulations; or is a male participant who is expecting to donate sperm from Day 1 (start of treatment) through 14 days after the last dose of study drug or longer if dictated by local regulations
  • Has any clinically-significant illness (other than HCV) or any other major medical
disorder that may interfere with treatment, assessment or compliance with the protocol or any medical/surgical conditions that may result in a need for hospitalization during the period of the study; or is currently under evaluation for a potentially clinically-significant illness (other than HCV)

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03143998

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT03143998   History of Changes  
Other Study ID Numbers: 5172-089  
Study First Received: May 4, 2017  
Last Updated: November 7, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.