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Deferiprone and Incretin Therapy for Wolfram Syndrome Type 2
NCT02882477Phase 3
Key facts
- Status
- Unknown
- Start
- Dec 2016
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- Hadassah Medical Organization
- Modality
- Small Molecules
- Drugs
- deferiprone
- Conditions
- Wolfram syndrome type 2 (WFS2)
01
Overview
Phase 3, open-label trial of deferiprone in Wolfram syndrome type 2 (WFS2) (2 arms), sponsored by Hadassah Medical Organization. Primary endpoints: Insulin levels in blood in response to Glucose Challenge at 5 months, Platelet aggregation to Adenosine diphosphate (ADP) and Collagen at 5 months and 4 more. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Deferiprone + Acetylcysteine
Deferiprone 20 mg/kg/day + Acetylcysteine 200 mg BID
Deferiprone + Acetylcysteine + Januet
Deferiprone 20 mg/kg/day + Acetylcysteine 200 mg BID + Sitagliptin/Metformin
03
Who it enrols
Patients of any age genetically and clinically diagnosed with Wolfram syndrome type 2. Patients with bone marrow disease or neutropenia are excluded.
04
Endpoints
Primary
Insulin levels in blood in response to Glucose Challenge
Platelet aggregation to Adenosine diphosphate (ADP) and Collagen
Nerve conduction velocity in VEP
HBA1C level
Daily glucose level measurement
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