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Clinical Trials in Poland / NCT05095727
Active, not recruiting Phase 1/2

A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)

NCT05095727 · tracked via the Priya Life Science Poland tracker
Sponsor
ModernaTX, Inc
Phase
Phase 1/2
Started
2022-06-01
Last updated
2025-12-15

Condition(s) studied

Glycogen Storage Disease

Investigational drug(s) / intervention(s)

mRNA-3745

mRNA-3745: Sterile frozen liquid dispersion for injection

Study summary

The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documented GSD1a with confirmation of biallelic gene encoding glucose-6-phosphatase-α (G6PC) mutations by genetic testing. * Absence of hospitalization for hypoglycemia in the 4 weeks prior to Screening Exclusion Criteria: * Solid organ transplant * Received gene therapy for GSD1a * Presence of liver adenoma \>5 centimeters (cm) in size * Diagnosis of type 1 or type 2 diabetes mellitus * Presence of liver adenoma with growth of \>2 cm or \>5 newly diagnosed liver adenomas, in the previous 2 years Note: Additional inclusion/exclusion criteria may apply, per protocol.

Primary outcome measure(s)

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation — Day 1 up to approximately 3.5 years

Trial sites (16)

FacilityCityRegionStatus
University of Connecticut Health Center Farmington Connecticut
Boston Children's Hospital Boston Massachusetts
Duke University Medical Center Durham North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Children's Hospital of Philadelphia Philadelphia Pennsylvania
The University of Texas Health Science Center at Houston Houston Texas
Baylor College of Medicine Houston Texas
University of Utah Salt Lake City Utah
Stollery Children's Hospital University of Alberta Edmonton Alberta
The Hospital for Sick Children Toronto Ontario
AP-HP - Hôpital Antoine Béclère Clamart France
CHRU Tours - Hopital Clocheville Tours France
Universitair Medisch Centrum Groningen Groningen Netherlands
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Regional Universitario de Malaga Málaga Spain

More ModernaTX, Inc. trials in Poland

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05095727 on ClinicalTrials.gov ↗ ← All trials in Poland