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CF 102

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Can-Fite Biopharma Ltd|Last Updated: Apr 15, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00790673A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1PHASE1 COMPLETED 32Jul 1, 2009Jul 1, 2011Apr 15, 20151 Israel
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Study Endpoints
Primary Endpoints
Adverse Event Profile of Repeated Dosing of CF102
16 weeks
Effect of Viral Load
16 weeks
Pharmacokinetic Behavior of CF102 During Repeated Dosing
16 weeks
Secondary Endpoints
Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects
16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCF102 1 mg qd
2EXPERIMENTALCF102 1 mg bid
3EXPERIMENTALCF102 1 mg bid; 16 weeks
5PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CF 102DRUGOral capsules
PlaceboDRUGMatching placebo capsules
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. 18 to 60 years of age 2. Body mass index ≤ 30 kg/m2 3. Either: 1. no evidence of cirrhosis, or liver fibrosis corresponding to Metavir Stages 0 to 31 on a liver biopsy performed within the past 2 years, or 2. a score of F0 or F1 on ActiTest-FibroTest performed within t...

Countries:Israel
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