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EMZ702

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Opko Health Inc.|Last Updated: Oct 18, 2019

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 Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00230854Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and RibavirinPHASE1 COMPLETED 28 — — Aug 1, 2005Jul 1, 2007Oct 18, 20192 Canada
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Secondary Endpoints
To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
EMZ702DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Hepatitis C virus (HCV) genotype 1 * Previous therapy with pegylated interferon and ribavirin * Documented previous treatment failure Exclusion Criteria: * Hepatic dysfunction * Coinfection with hepatitis B or HIV * Other unrelated liver diseases * Liver cancer

Countries:Canada
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