RabiesPhase 3NCT02912845
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
A Phase 3 study testing KamRAB - HRIG in people with Rabies, run by Kamada, Ltd. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Rabies
- What is being tested?
- KamRAB - HRIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 13 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Rabies
- Being tested
- KamRAB - HRIG
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KamRAB - HRIGDrug
wound infiltration or IM injection
| Study group | Role | What they receive |
|---|---|---|
| 20 IU/kg KamRAB + Active Anti-Rabies Vaccine | Experimental | Not described Receives: Drug: KamRAB - HRIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Measured: Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Measured: Within 84 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start1 Aug 2016
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kedrion S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912845
- Sponsor's protocol ID
- KamRAB-004
- Status last verified
- Feb 2019
- First submitted
- 18 Sep 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
- ClinicalTrials.gov ID
- NCT02912845
- Acronym / sponsor ID
- KamRAB-004
- Conditions
- Rabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kedrion S.p.A.
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 IU/kg KamRAB + Active Anti-Rabies Vaccine | Experimental | Drug: KamRAB - HRIG |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KamRAB - HRIGwound infiltration or IM injection | Drug | 20 IU/kg KamRAB + Active Anti-Rabies Vaccine |
Primary outcome
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
Time frame: Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
Time frame: Within 84 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KamRAB - HRIG in people with Rabies, run by Kamada, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment (time frame: Within 14 days from treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.