EVALUATION OF THE EFFICACY OF THE TREATMENT WITH ACE-INHIBITORS ON THE RENAL DAMAGE IN PATIENTS AFFECTED BY GLYCOGEN STORAGE DISEASE TYPE 1 AND OF THE VITAMINE E ON NEUTROPENIA OF PATIENTS WITH GSD1b - GSD1: study of specific therapeutic interventio

• Conditions: As concern objective number 1: Patients affected by glycogen storage disease (GSD) type 1a and patients affected by GSD1b with renal dysfunction including glomerular hyperfiltration, microalbuminuria and/or proteinuria As concern objective number 2: Patients affected by GSD1b showing neutropenia; MedDRA version: 9.1Level: LLTClassification code 10018464Term: Glycogen storage disease type I

• Registration Number: EUCTR2006-005449-12-IT
• Lead Sponsor: Dipartimento di Pediatria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-23
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria will be represented by the demonstration of the diagnosis of GSD 1a-either by enzyme studies and/or mutation analysis-and GSD1b-either by enzyme studies and/or mutation analysis
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion criteria will be the inability to comply with the protocol and with the therapy.

Pregnancy and breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified