Testing granulocyte-colony stimulating factor (GCSF) in patients with Friedreich Ataxia
Phase 1
- Conditions
- Friedreich AtaxiaMedDRA version: 20.0 Level: LLT Classification code 10003592 Term: Ataxia cerebellar System Organ Class: 100000004852MedDRA version: 20.0 Level: PT Classification code 10017374 Term: Friedreich's ataxia System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-003084-34-GB
- Lead Sponsor
- niversity of Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
Genetic diagnosis of FRDA
Age of over 18 and under 60
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Pregnancy, breastfeeding or lactation
Significant abnormalities on baseline bloods (full blood count, renal and liver function)
Previous diagnosis of haematological disorder (including malignancy)
Previous history of splenomegaly
Previous history of autoimmune disease
Previous history of pulmonary infiltrates, pulmonary fibrosis or haemoptysis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method