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Peginterferon Lambda-1a

Phase 3

Hepatitis C Virus (HCV) | Monoclonal antibody | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 28, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01754974Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis CPHASE3 COMPLETED 40 — — Mar 1, 2013Sep 1, 2014Jan 28, 201516 Czechia, Mexico +1
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Study Endpoints
Primary Endpoints
Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects
Up to 48 weeks of treatment

* ANC = Absolute Neutrophil Count * Hb = Hemoglobin

Secondary Endpoints
Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ)
At Post-Treatment Follow-up Week 24
Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
On treatment Week 4 (of an up to 48-week treatment period)
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Up to 48 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Peginterferon Lambda-1a + RibavirinEXPERIMENTALPeginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Peginterferon alfa-2a + RibavirinACTIVE_COMPARATORPeginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Interventions
NameTypeDescription
Peginterferon Lambda-1aBIOLOGICAL -
RibavirinDRUG -
Peginterferon alfa-2aBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Chronic hepatitis C, Genotype 1 * HCV RNA ≥100,000 IU/mL at screening * Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease * Naïve to prior anti-HCV t...

Countries:CzechiaMexicoSouth Korea
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