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PEG-IFN alfa-2a, Tenofovir

Phase 2

Hepatitis D | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jan 29, 2018

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00932971HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta HepatitisPHASE2 COMPLETED 70Jun 1, 2009Aug 2, 2017Jan 29, 201810 Germany, Greece +1
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Study Endpoints
Primary Endpoints
Negativation of HDV-RNA at the end of therapy
week 96
Secondary Endpoints
Negativation of HDV-RNA at week 48 of treatment
week 48
Negativation of HDV-RNA 24 weeks after the end of treatment
week 120
Normalization of ALT levels at the end of treatment and at the end of follow-up
week 96 and week 356
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PEG-IFN alfa-2a plus placeboPLACEBO_COMPARATORPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus placebo once daily, orally
PEG-IFN alfa-2a plus TenofovirACTIVE_COMPARATORPegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus Tenofovir disoproxilfumarat 245mg once daily, orally
Interventions
NameTypeDescription
PEG-IFN alfa-2a, TenofovirDRUGPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
PEG-IFN alfa-2a, placeboDRUGPegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Written informed consent. * Age \> 18 years. * Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period. * Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values ta...

Countries:GermanyGreeceRomania
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