Post-marketing Study of KamRAB Administered as a Single D... | NCT02912845

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

NCT02912845

Sponsor

Kamada, Ltd.

Status

Completed

Last Update Posted

Sep 5, 2021Actual

Enrollment

30Actual

Phase

Phase 3

Conditions

Rabies

Interventions

KamRAB - HRIG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Nov 13, 2019Actual

Completion Date

Nov 13, 2019Actual

First Submitted Date

Sep 18, 2016

First Submission Date that Met QC Criteria

Sep 22, 2016

First Posted Date

Sep 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 5, 2021Actual

Name	Class
Kedrion S.p.A.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
20 IU/kg KamRAB + Active Anti-Rabies Vaccine	Experimental		Drug: KamRAB - HRIG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KamRAB - HRIG	Drug	wound infiltration or IM injection	20 IU/kg KamRAB + Active Anti-Rabies Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACH		Little Rock	Arkansas	12345	United States

Condition Browse Module

MeSH Terms

ID	Term
D011818	Rabies

Ancestor Terms

ID	Term
D018353	Rhabdoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided