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Comparator: Fine needle aspiration biopsy

Phase 1

Chronic Hepatitis C | Unknown | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 22, 2015

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
NO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00828269Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)PHASE1 COMPLETED 12Apr 1, 2009Mar 1, 2010Apr 22, 2015 -
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Study Endpoints
Primary Endpoints
To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.
5 weeks
Secondary Endpoints
Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.
5 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1NO_INTERVENTIONLiver tissue biopsy
Interventions
NameTypeDescription
Comparator: Fine needle aspiration biopsyPROCEDUREVisit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver. Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient has chronic hepatitis C (Genotype 1) * Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy Exclusion Criteria: * Patient has received any approved or investigational drug...

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