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OraQuick HCV Rapid Antibody Test

Phase 1

Hepatitis C | Unknown | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 2, 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 Enrollment3,051
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03195205Identification to Elimination in HCV-Infected IndividualsEARLY_PHASE1 COMPLETED 3,051Jun 1, 2017Apr 20, 2020Jul 2, 20201 United States
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Study Endpoints
Primary Endpoints
Positivity rates
20 - 40 minutes

The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.

Secondary Endpoints
Linked to care
1 - 3 months
Treatment
8 - 24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
High-Risk PatientsOTHEROraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Interventions
NameTypeDescription
OraQuick HCV Rapid Antibody TestDIAGNOSTIC_TESTHCV Screening
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects will be included in the study if the following criteria is met: 1. The subject must be an Opioid Substitution Treatment patient. 2. The subject must fall into another high-risk population for the HCV. Exclusion Criteria: Subjects may be excluded from the study if the...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials