NCT06208215 - RZ358 Treatment for Congenital Hyperinsulinism | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 11, 2024

Primary Completion Date

April 4, 2025

Study Completion Date

September 28, 2026

Conditions

Congenital Hyperinsulinism

Interventions

DRUG

RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC

Participants ≥1 year old who receive SOC therapy and 5 mg/kg of RZ358 or placebo

DRUG

RZ358 (10 mg/kg) or Placebo + SOC

Participants ≥1 year old who receive SOC therapy and 10 mg/kg of RZ358 or placebo

DRUG

RZ358 (5-10 mg/kg) + SOC

Infant participants from ≥3 months to \<1 year old who receive SOC therapy + RZ358 starting at 5 mg/kg and increasing to 10 mg/kg of RZ358, as needed, per the protocol schedule

Trial Locations (24)

123

RECRUITING

Rezolute Investigative Site, Seeb, Oman, Seeb

5000

RECRUITING

Rezolute Investigative Site, Odense, Denmark, Odense

9010

RECRUITING

Rezolute Investigative Site, Varna, Bulgaria, Varna

11001

RECRUITING

Rezolute Investigative Site, Al Mafraq, United Arab Emirates, Al Mafraq

11426

RECRUITING

Rezolute Investigative Site, Riyad, Saudi Arabia, Riyāḑ

11471

RECRUITING

Rezolute Investigative Site, Riyad, Saudi Arabia, Riyāḑ

13353

RECRUITING

Rezolute Investigative Site, Berlin, Germany, Berlin

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

40225

RECRUITING

Rezolute Investigative Site, Dusseldorf, Germany, Düsseldorf

41013

RECRUITING

Rezolute Investigative Site, Sevilla, Spain, Seville

69677

RECRUITING

Rezolute Investigative Site, Bron, France, Bron

75015

RECRUITING

Rezolute Investigative Site, Paris, France, Paris

76104

NOT_YET_RECRUITING

Cook Children's Medical Center, Fort Worth

100000

RECRUITING

Rezolute Investigative Site, Hà Nội, Vietnam, Hà Nội

5265601

RECRUITING

Rezolute Investigative Site, Ramat Gan, Israel, Ramat Gan

H4A 3J1

NOT_YET_RECRUITING

Rezolute Investigative Site, Montreal, Canada,, Montreal

S7N 0W8

RECRUITING

Rezolute Investigative Site, Saskatoon, Canada, Saskatoon

0159

RECRUITING

Rezolute Investigative Site, Tbilisi, Georgia, Tbilisi

115 27

RECRUITING

Rezolute Investigative Site, Athens, Greece, Athens

Unknown

RECRUITING

Rezolute Investigative Site, Al Rayyan, Qatar, Al Rayyan

08035

RECRUITING

Rezolute Investigative Site, Barcelona, Spain, Barcelona

06800

RECRUITING

Rezolute Investigative Site, Ankara, Turkey, Ankara

WC1N 3JH

RECRUITING

Rezolute Investigative Site, London, United Kingdom, London

M13 9WL

RECRUITING

Rezolute Investigative Site, Manchester, United Kingdom, Manchester