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Albinterferon alfa 2b

Phase 2

Chronic Hepatitis C | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 8, 2020

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment555
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00759200Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C PatientsPHASE2 COMPLETED 525Oct 1, 2008Dec 1, 2010Nov 16, 201655 Australia, Canada +10
NCT00724776Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C PatientsPHASE1 COMPLETED 30Jul 1, 2008 -Dec 8, 20201 Japan
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Study Endpoints
Primary Endpoints
Adverse events
at every visit
Safety and tolerability after single dose
5 weeks after single dose
Secondary Endpoints
Viral load
at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
5 weeks after single dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
alb-interferon arm 1EXPERIMENTAL -
alb-interferon arm 2EXPERIMENTAL -
alb-interferon arm 3EXPERIMENTAL -
alb-interferon arm 4EXPERIMENTAL -
peg-interferonACTIVE_COMPARATOR -
1EXPERIMENTALOpen-label treatment with albinterferon alfa 2b escalating single dose
Interventions
NameTypeDescription
alb-interferon alfa 2bDRUG900 mcg every 4 weeks
peg-interferonDRUGPeg-interferon alfa 2a: 180 mcg 1x per wk.
Albinterferon alfa 2bBIOLOGICALrecombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites55

Inclusion Criteria: * Age of 18 years or older * Clinical diagnosis of chronic hepatitis C * Infection with HCV genotype 2 or 3 * No previous IFNα-based therapy Exclusion Criteria: * Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing * Fertil...

Countries:AustraliaCanadaFranceGermanyGreeceIndiaItalyPolandSpainTaiwanThailandUnited KingdomJapan
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