An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Completed · Phase 2
Conditions studied: Congenital Hyperinsulinism
In brief
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Key facts
- Study ID
- NCT04538989
- Run by
- Rezolute
- People needed
- 23
- Starts
- 2020-02-24
- Expected to finish
- 2022-08-19
- Last updated by the study team
- 2025-05-28
Who can join
Age: 2 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism
- Able to provide written informed consent or, as applicable, assent
- Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, during Screening
- Willingness to use contraception if of child-bearing potential
You may not qualify if…
- Out of range blood work for study entry
- Body Mass index outside of study entry criteria
- History of malignancy
- Clinically significant diseases, seropositivity for HIV, hepatitis B or C antibody
- Use of systemic corticosteroids within 30 days before Screening
- Known or suspected allergy to the study drug
- Recent use of an investigational drug or treatment, or participation in an investigational study
- Pregnant or lactating women
- History of drug abuse or excessive alcohol use
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- SHAT Children diseases "Prof. Dr. Ivan Mitov" — Sofia, Bulgaria
- Medical University of Varna UMHAT "St. Marina" — Varna, Bulgaria
- Research Institute of the McGill University Health Centre — Monteral, Qubec, Canada
- Odense University Hospital — Odense, Denmark
- LTD "Pediatric Surgery Centre" — Tbilisi, Georgia
- Magdeburg University Clinic Center (Otto-von-Guericke Universität) — Magdeburg, Germany
- Edmond & Lilly Safra's Children Hospital — Ramat Gan, Tel-Hashomer, Israel
- Hadassah Har Hazofim MC - Division of Pediatric Endocrinology — Jerusalem, Israel
- Endocrinology research center — Moscow, Russia
- Hospital Universitari Vall d' Hebron — Barcelona, Spain
- Adana Cukurova University Balcalı Hospital — Sarıçam, Adana, Turkey (Türkiye)
- Hacettepe University — Çankaya, Ankara, Turkey (Türkiye)
- SBÜ Gazi Yaşargil Eğitim ve Araştirma Hastanesi — Kayapınar, Diyarbakır, Turkey (Türkiye)
- Erzurum City Hospital — Yakutiye, Erzurum, Turkey (Türkiye)
- Great Ormond Street Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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