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Palivizumab

Phase 3

Respiratory Syncytial Virus Infection | Small molecule | Respiratory |AbbVie Inc.|Last Updated: Jun 17, 2013

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01466062Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical ConditionsPHASE3 COMPLETED 28 — — Aug 1, 2011Apr 1, 2012Jun 17, 20136 Japan
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Study Endpoints
Primary Endpoints
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Day 1 (Screening), Day 31, Day 121

Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).

Secondary Endpoints
Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PalivizumabEXPERIMENTAL15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of severe respiratory syncytial virus (RSV) during the RSV season.
Interventions
NameTypeDescription
PalivizumabDRUG -
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Eligibility Criteria
Age RangeN/A — 24 Months
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Availability of parent or legal guardian who is capable and willing to give written informed consent for his/her newborn, infant or young child to participate this study. 2. Japanese newborn, infant or young child at age of 24 months or less. 3. The subject must meet at least...

Countries:Japan
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