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intramuscular hepatitis B virus immune globulin

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Grifols, S.A.|Last Updated: May 8, 2009

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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00895713Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver TransplantationPHASE2 COMPLETED 18 — — Nov 1, 2004Jul 1, 2005May 8, 20092 Italy
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Study Endpoints
Primary Endpoints
Mean trough serum HBsAg Ab titer
Months 4-6
Secondary Endpoints
HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period
Week 2 - 7 months
Mean trough HBsAg Ab titer
4 months
Individualised trough HBsAg Ab titer
Week 2 - 7 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
im HBIG GrifolsEXPERIMENTAL -
Interventions
NameTypeDescription
intramuscular hepatitis B virus immune globulinDRUGBiweekly intramuscular doses of 2000 IU administered during 6 consecutive months
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female. 2. Age \> 18 years and \< 70 years. 3. OLT recipient for HBV infection-related disease for \> 18 months before inclusion in the clinical trial. 4. Serum HBsAg-positive within 3 months before transplantation. 5. Serum HBsAg-negative just before inclusion in the...

Countries:Italy
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