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KamRAB- HRIG

Phase 3

Rabies | Small molecule | Infectious Disease |Kamada Ltd.|Trials Updated: Sep 5, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

KamRAB- HRIG clinical trials

KamRAB- HRIG · 1 trial · 1 indication

Phase 3 1
NCT02912845Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to RabiesRabies
COMPLETED30 Analytics
PHASE3COMPLETED
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
RabiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Within 84 days of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
20 IU/kg KamRAB + Active Anti-Rabies VaccineEXPERIMENTAL -

Interventions

NameTypeDescription
KamRAB - HRIGDRUGwound infiltration or IM injection
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Eligibility Criteria

Age Range0 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy children (male and female) ages 0 months to \<17 years. * Have been exposed or possibly exposed to rabies. * Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection. * Have documented informed consent from the child's parent(s) or legal guardi...

Countries:United States
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Frequently asked questions about KamRAB- HRIG

What is KamRAB- HRIG used for?

KamRAB- HRIG is used for rabies post-exposure prophylaxis in children exposed to rabies. It is given as a single dose together with an active rabies vaccine. Kamada Ltd. developed it as a human rabies immune globulin product for passive immunization after suspected rabies exposure.

Who makes KamRAB- HRIG?

KamRAB- HRIG is developed by Kamada Ltd., an Israeli biopharmaceutical company whose shares trade under the ticker KMDA. Kamada is the sponsor of the clinical study of KamRAB- HRIG in children exposed to rabies conducted in the United States.

What phase is KamRAB- HRIG in?

KamRAB- HRIG is in Phase 3 development. Its single registered trial, NCT02912845, is listed as a Phase 3 post-marketing study and has completed. The study enrolled 30 children exposed to rabies in the United States and was an uncontrolled, non-randomized, open-label design.

What clinical trials is KamRAB- HRIG in?

KamRAB- HRIG has been studied in one registered clinical trial, NCT02912845, titled a post-marketing study of KamRAB administered as a single dose with active rabies vaccine in children exposed to rabies. The trial was Phase 3, completed, enrolled 30 participants, and was conducted in the United States.

Is KamRAB- HRIG the same as KamRAB - HRIG?

Yes, KamRAB- HRIG and KamRAB - HRIG refer to the same product from Kamada Ltd. The only difference is spacing and punctuation in the name. Both spellings point to the same human rabies immune globulin candidate studied in children exposed to rabies under trial NCT02912845.