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daclatasvir

Phase 3

Hepatitis C | Small molecule | Infectious Disease |China Pharma Holdings, Inc.|Last Updated: Jan 9, 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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03004625Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAVPHASE3 COMPLETED 70Nov 1, 2016Apr 1, 2018Jan 9, 20191 Taiwan
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Study Endpoints
Primary Endpoints
To determine the treatment efficacy (SVR12) of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs
6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid

SVR12 is defined as undetectable HCV RNA 12 weeks throughout 12 weeks of post-treatment follow-up peroid

Secondary Endpoints
To evaluate the number of participants with treatment-related adverse events of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs.
3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study ArmEXPERIMENTALHCV-1b patients without baseline NS5A resistance-associated variants receiving Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks. (daclatasvir, asunaprevir plus ribavirin)
Interventions
NameTypeDescription
daclatasvirDRUGto evaluate the treatment efficacy and safety of the drug in HCV patients
asunaprevirDRUGto evaluate the treatment efficacy and safety of the drug in HCV patients
RibavirinDRUGto evaluate the treatment efficacy and safety of the drug in HCV patients
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Treatment naïve, interferon-experienced, interferon-intolerant or interferon-ineligible, HCV genotype 1b patients with compensated liver disease. 2. Patients with compensated liver cirrhosis will be capped at 40%. Cirrhosis is defined as any one of the following: * Liv...

Countries:Taiwan
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Competitive Landscape -Hepatitis C 11 trials