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

Hepatitis C Clinical Trial

Official title:

A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252016
• Other study ID #: 5172-065
• Secondary ID: 2014-002356-27
• Status: Completed
• Phase: Phase 3
• Start date: October 22, 2014
• Est. completion date: June 14, 2016

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 14, 2016
• Est. primary completion date: December 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Grazoprevir + Elbasvir
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
• Placebo
Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Hézode C, Colombo M, Bourlière 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)	The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 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.	24 weeks after completing study therapy (Week 36)