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Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

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ClinicalTrials.gov Identifier: NCT02912845
Recruitment Status : Unknown
Verified February 2019 by Kamada, Ltd..
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Kedrion S.p.A.
Information provided by (Responsible Party):
Kamada, Ltd.

Study Description
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Brief Summary:
The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to <17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).

Condition or disease Intervention/treatment Phase
Rabies Drug: KamRAB - HRIG Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arms and Interventions
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Arm Intervention/treatment
Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine Drug: KamRAB - HRIG
wound infiltration or IM injection


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment [ Time Frame: Within 14 days from treatment ]
  2. Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment [ Time Frame: Within 84 days of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 guardian(s) and assent from the child if appropriate.

Exclusion Criteria:

  • History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
  • Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912845


Locations
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United States, Arkansas
ACH Recruiting
Little Rock, Arkansas, United States, 12345
Contact: Hobart-Porter    501-364-1050    nwhobartporter@uams.edu   
Sponsors and Collaborators
Kamada, Ltd.
Kedrion S.p.A.
More Information
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Responsible Party: Kamada, Ltd.
ClinicalTrials.gov Identifier: NCT02912845    
Other Study ID Numbers: KamRAB-004
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases