An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Public ClinicalTrials.gov record NCT04538989. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Study identification
- NCT ID
- NCT04538989
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Rezolute
- Other
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Interventions
- RZ358 Sequential Group Cohort 1 Drug
- RZ358 Sequential Group Cohort 2 Drug
- RZ358 Sequential Group Cohort 3 Drug
- RZ358 Sequential Group Cohort 4 Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 23, 2020
- Primary completion
- Apr 4, 2022
- Completion
- Aug 18, 2022
- Last update posted
- May 27, 2025
2020 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04538989, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2025 · Synced Jul 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04538989 live on ClinicalTrials.gov.