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pegIFN

Phase 2

Hepatitis B Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 9, 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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment197
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01204762Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e AntigenPHASE2 COMPLETED 197 — — Nov 1, 2010Dec 1, 2013Oct 9, 201553 United States, Australia +9
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Study Endpoints
Primary Endpoints
Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion
24 weeks post-dosing (Week 72)
Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events
Week 24
Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs
Up to 84 Weeks
Secondary Endpoints
Part A: Proportion of subjects who achieve an hepatitis B virus Deoxyribonucleic acid levels (HBV DNA) < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - High Pure System (HPS) assay
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Part A: Mean change from baseline in log10 HBV DNA levels over time (Proportion of subjects with Alanine amino transferase (ALT) normalization (≤ 1 x upper limit of normal (ULN))
Baseline (Day 1), Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN)
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A Arm 1: pegIFN (180 μg)EXPERIMENTAL -
Part A Arm 2: pegIFNα-2aACTIVE_COMPARATOR -
Part B: pegIFN lambda + EntecavirEXPERIMENTAL -
Interventions
NameTypeDescription
pegIFNDRUGSyringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks
pegIFNα-2aDRUGSyringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks
PegIFN lambdaDRUGSyringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
EntecavirDRUGTablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Infection with the hepatitis B virus (HBV) and positive for the hepatitis B e antigen * Between the ages of 18 and 70 * Have not been previously treated with an interferon * HBV nucleos(t)ide-naive Exclusion Criteria: * Not infected with the hepatitis C virus (HCV), hepatiti...

Countries:United StatesAustraliaCanadaFranceGermanyHong KongItalyNetherlandsSingaporeSouth KoreaTaiwan
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