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Elbasvir/Grazoprevir Fixed Dose Combination

Phase 3

Chronic HCV Infection | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 1, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02973503Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe FibrosisPHASE3 COMPLETED 117 — — Jan 11, 2017Apr 1, 2019Oct 1, 20201 France
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Study Endpoints
Primary Endpoints
Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12).
at 12 weeks post-treatment

Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests

Secondary Endpoints
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Asthenia Reported
Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Headache Reported
between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Digestive Disorders Reported
Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Elbasvir/GrazoprevirEXPERIMENTALevaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
Interventions
NameTypeDescription
Elbasvir/Grazoprevir Fixed Dose CombinationDRUGEvaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Willing and able to provide written informed consent * Male or female, age ≥ 18 years * Body Mass Index (BMI) ≥ 18 kg/m2 * HCV RNA ≥ 100 000 IU/mL at Screening * Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Po...

Countries:France
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