RECRUITING

RZ358 Treatment for Congenital Hyperinsulinism

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

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients with Congenital Hyperinsulinism

Quick Facts

Study Start:2024-01-11
Study Completion:2026-09-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06208215

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:3 Months to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
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

Study Contact

Davelyn Hood, MD
CONTACT
6502064507
clinicaltrials@rezolutebio.com
Gopal Saha, MD
CONTACT
6502064507
clinicaltrials@rezolutebio.com

Principal Investigator

Gopal Saha, MD
STUDY_DIRECTOR
Rezolute

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Rezolute

  • Gopal Saha, MD, STUDY_DIRECTOR, Rezolute

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 Date2024-01-11
Study Completion Date2026-09-28

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2026-09-28

Terms related to this study

Keywords Provided by Researchers

  • Hypoglycemia
  • Congenital Hyperinsulinism
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Pancreatic Diseases
  • Digestive System Diseases
  • Hyperinsulinism

Additional Relevant MeSH Terms

  • Congenital Hyperinsulinism