TERMINATED

Survey of Human Rabies Immune Globulin Safety in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

Official Title

Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children

Quick Facts

Study Start:2023-02-22
Study Completion:2025-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05382650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Michael Sirimaturos, PharmD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Michael Sirimaturos, PharmD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22
Study Completion Date2025-10-15

Study Record Updates

Study Start Date2023-02-22
Study Completion Date2025-10-15

Terms related to this study

Keywords Provided by Researchers

  • Pediatrics
  • Rabies post-exposure prophylaxis
  • Rabies PEP
  • Rabies immune globulin
  • Rabies IG
  • Adverse events

Additional Relevant MeSH Terms

  • Rabies
  • Rabies Human
  • Rabies Virus Infection
  • Pediatrics