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

• Sponsor: Kamada, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02912845
• Collaborator: Kedrion S.p.A. (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 39.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

• Study Type: Interventional
• Actual 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: Aug 1, 2016
• Actual Primary Completion Date: Nov 13, 2019
• Actual Study Completion Date: Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine	Drug: KamRAB - HRIG; wound infiltration or IM injection

Outcome Measures

Primary Outcome Measures

1. Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment [Within 14 days from treatment]

2. Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment [Within 84 days of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	ACH	Little Rock	Arkansas	United States	12345

Sponsors and Collaborators

• Kamada, Ltd.
• Kedrion S.p.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamada, Ltd.
• ClinicalTrials.gov Identifier: NCT02912845
• Other Study ID Numbers: KamRAB-004
• First Posted: Sep 23, 2016
• Last Update Posted: Sep 5, 2021
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rabies

Study Results

No Results Posted as of Sep 5, 2021