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Rabies treatment safety study in kids halted early

NCT ID NCT05382650

Knowledge-focused Sponsor: The Methodist Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to check the safety of a rabies immune globulin shot (HyperRAB) in children who were treated after an animal bite. It included 35 kids aged 17 and under across several emergency rooms. The study was stopped early, so results are limited, but the goal was to see if the shot caused any side effects within a few days to a month.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

35 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patients who received HRIG 300 IU/mL as part of routine medical care for rabies PEP during an ED visit in up to 5 study sites in the United States

Ages

Up to 17 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit 2. Aged ≤17 years Exclusion Criteria 1. HRIG 300 IU/mL dose given is \<18 IU/kg or \>22 IU/kg 2. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure 3. Patient has a history of rabies vaccine or rabies immune globulin administration 4. Legally authorized representative (parent) does not speak English if patient is \<7 years old 5. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old 6. Inability to obtain consent 1. More than 3 days passed since HRIG 300 IU/mL administration prior to screen 2. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration 3. Legally authorized representative (parent) and/or patient declined participation 7. Administration sites for HRIG are unknown

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Conditions

The condition(s) this trial relates to.

rabies prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatrics Rabies Rabies human Rabies virus infection

Contacts and locations

Locations

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.