EUCTR2018-004191-35-BE
Active, not recruiting
Phase 1
Evaluation of the safety and efficacy of administration of Empagliflozin in a new treatment for neutropenia in patients with Glycogen Storage Disease type 1b (GSD1b) and G6PC3 deficiency. - GLYCO-1B
Conditions(1) Severe Congenital Neutropenia type 4 (SNC4) due to a deficiency in G6PC3, a phosphatase of the endoplasmic also known a Ubiquitous glucose-6-phosphatase and (2) the neutropenia in Glycogen Storage Disease type 1b due to a deficiency in the glucose-6-phosphate transporter (G6PT / SLC37A4) of the endoplasmic reticulum.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- (1) Severe Congenital Neutropenia type 4 (SNC4) due to a deficiency in G6PC3, a phosphatase of the endoplasmic also known a Ubiquitous glucose-6-phosphatase and (2) the neutropenia in Glycogen Storage Disease type 1b due to a deficiency in the glucose-6-phosphate transporter (G6PT / SLC37A4) of the endoplasmic reticulum.
- Sponsor
- Cliniques universitaires Saint-Luc
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Glycogenosis type 1b confirmed by biochemical analyzes and / or genetic analysis.
- •\- Alternatively, G6PC3 deficiency confirmed by genetic analysis
- •\- Informed consent signed by the recipient and / or parents / assigns.
- •\- Information and agreement of the referring medical team.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Presence of advanced fibrosis (Metavir F4\) or cirrhosis.
- •\- Impossibility of long\-term and / or non\-compliance monitoring.
- •\- Other medical problems which, in the opinion of the physicians in charge of the patient, would constitute a contraindication to the procedure.
Outcomes
Primary Outcomes
Not specified
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