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Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01932762
First received: August 27, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) (a second-generation protease inhibitor) used in combination with/or without 50 mg of elbasvir (MK-8742) (an NS54A inhibitor) and/or ribavirin (RBV) in treating non-cirrhotic treatment-naïve (TN) participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection.


Condition Intervention Phase
Hepatitis C
Drug: Grazoprevir
Drug: Elbasvir
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial to Study the Efficacy and Safety of a Combination Regimen of MK-5172 and MK-8742 With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Genotype 2 Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12) [ Time Frame: From Treatment Week (TW) 1 to Follow-up Week (FW) 12 (up to 24 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AE, Drug-Related SAE, or Discontinuation Due to AE [ Time Frame: From TW1 through FW 24 (up to 36 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to First Achievement of Undetectable HCV RNA [ Time Frame: From TW1 through FW 24 (up to 36 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Undetectable HCV RNA [ Time Frame: From TW 1 through TW 12 (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HCV RNA <25 IU/mL [ Time Frame: From TW 1 through TW 12 (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving SVR4 [ Time Frame: From TW1 through FW 4 (up to 16 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving SVR24 [ Time Frame: From TW1 through FW 24 (up to 36 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: grazoprevir + elbasvir + RBV
During Part A of the study, GT2 participants will receive 100 mg grazoprevir + 50 mg elbasvir + standard weight-based dosing of RBV for 12 weeks.
Drug: Grazoprevir
100 mg every day (QD) orally
Drug: Elbasvir
50 mg QD orally
Drug: Ribavirin
Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1
Other Name: Rebetol™
Experimental: Part B: grazoprevir + RBV
During Part B of the study, GT2 participants will receive 100 mg grazoprevir + standard weight-based dosing of RBV for 12 weeks.
Drug: Grazoprevir
100 mg every day (QD) orally
Drug: Ribavirin
Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1
Other Name: Rebetol™
Experimental: Part B: grazoprevir + elbasvir + RBV
During Part B of the study, GT4/GT5/GT6 participants will receive 100 mg grazoprevir + 50 mg elbasvir + standard weight-based dosing of RBV for 12 weeks.
Drug: Grazoprevir
100 mg every day (QD) orally
Drug: Elbasvir
50 mg QD orally
Drug: Ribavirin
Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1
Other Name: Rebetol™
Experimental: Part B: grazoprevir + elbasvir
During Part B of the study, GT4/GT5/GT6 participants will receive 100 mg grazoprevir + 50 mg elbasvir for 12 weeks.
Drug: Grazoprevir
100 mg every day (QD) orally
Drug: Elbasvir
50 mg QD orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Parts A and B: -Body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs) -Has absence of cirrhosis -Agrees to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential). Part A only: -Has chronic HCV GT2 infection Part B only: -Has chronic HCV GT2, GT4, GT5, or GT6 infection

Exclusion Criteria:

Parts A and B:

-Is not treatment naïve (participant has had previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV) -Is determined to be coinfected with hepatitis B virus (HBsAg positive) or HIV -Has evidence of, or is under evaluation for, hepatocellular carcinoma (HCC) -Has a clinical diagnosis of substance abuse including the following specified drugs within specified timeframes: Alcohol, intravenous drugs, inhalational, psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs (within 1 year of the screening visit), is receiving opiate agonist substitution therapy (within 1 year of screening visit), or excessive historic marijuana use -Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years -Female participant who is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment, or male participant who is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment -Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. -Has uncontrolled diabetes (documented HbA1c >8.5%)

Part A only:

-Has non GT2 HCV infection

Part B only:

-Has HCV infection with a genotype other than GT2, GT4, GT5 or GT6

  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: NCT01932762

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01932762     History of Changes
Other Study ID Numbers: 5172-047, 2013-002169-21
Study First Received: August 27, 2013
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014