Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)

Hepatitis C Clinical Trial

Official title:

A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Boceprevir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1 Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02204475
• Other study ID #: 5172-066
• Secondary ID: 2014-001841-25
• Status: Withdrawn
• Phase: Phase 3
• First received: July 28, 2014
• Last updated: October 13, 2015
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has HCV RNA = 10,000 IU/mL at the time of screening

• Has documented chronic HCV GT 1 with no evidence of non-typeable or mixed GT infection

• Is cirrhotic or non-cirrhotic

• Has HCV treatment status that is treatment naïve, PR null responder; PR partial responder; or prior PR relapser

• If human immunodeficiency virus (HIV) co-infected (HIV-1) must be naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART treatment while participating in this trial, or be on HIV ART for at least 8 weeks prior to trial entry (no changes in HIV regimen are allowed within 4 weeks of registration); must also have at least one viable antiretroviral therapy alternative beyond their current regimens in the event of HIV virologic failure and the development of antiretroviral drug resistance

• Use an acceptable method of contraception or not be of childbearing potential

Exclusion Criteria:

• Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease

• Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive)

• Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy

• Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

• Has pre-existing psychiatric condition(s)

• Has clinically-relevant drug or alcohol abuse within 12 months of screening

• Is a female and is pregnant or breast-feeding, or expecting to become pregnant or donate eggs from Day 1 throughout treatment and until at least 6 months after the last dose of study medication, or longer if dictated by local regulations; or is a male subject and is planning to impregnate or provide sperm donation

• Has any preexisting condition or prestudy laboratory abnormality, electrocardiogram (ECG) abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering the study drug(s) to the subject

• Has a life-threatening severe AE (SAE) during the screening period

• Has evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Grazoprevir/Elbasvir
Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).
• Boceprevir
Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
• PegIntron
Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
• Ribavarin
Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving SVR12		Up to Week 60	No
Secondary	Proportion of TN participants achieving SVR12		Up to Week 60	No
Secondary	Number of participants experiencing an adverse event (AE)		Up to Week 72	Yes
Secondary	Number of participants withdrawing from study treatment due to AEs		Up to Week 72	Yes
Secondary	Proportion of PTF participants achieving SVR12		Up to Week 60	No