Experimental Study Protocol on Treatment with plasma transfusions in Patients affected by type VI Osteogenesis Imperfecta

Phase 1

• Conditions: type VI Osteogenesis Imperfecta; MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002622-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Children between 1 and 18 years of age, affected by type VI OI, genetically and biochemically confirmed.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

- Previous transfusional adverse events.
- Need of transfusions for other reasons

Study & Design

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