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Ypeginterferon alfa-2b

Phase 2

Chronic Hepatitis B | Small molecule | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Jan 25, 2017

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02332473A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis BPHASE2 COMPLETED 110 — — Jun 1, 2014Aug 1, 2016Jan 25, 201712 China
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Study Endpoints
Primary Endpoints
Percentage of HBeAg seroconversion at the end of treatment
week 48
Secondary Endpoints
Percentage of HBsAg undetectable and seroconversion at the end of treatment
week 48
Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48
week 12, 24, 36 and 48
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48
week 12, 24, 36, and 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AACTIVE_COMPARATORYpeginterferon alfa-2b,sc. Qw. 48 weeks.
Arm BEXPERIMENTALYpeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13.
Interventions
NameTypeDescription
Ypeginterferon alfa-2bDRUG -
Granulocyte-macrophage colony stimulating factorDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * 18yrs≤age≤65yrs. * 17≤BMI(body mass index)≤28. * HBsAg positive≥6 months. * Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening. * 2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening. * Pregnancy test must be negative for female patients of childbearin...

Countries:China
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