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rhGH for Myopathy in Cystinosis
NCT02124070Phase 2
Key facts
- Status
- Withdrawn
- Start
- Mar 2014
- Primary completion
- Nov 2015
- Sponsor
- National Human Genome Research Institute
- Modality
- Hormone, rProtein (Recombinant Protein), Biologic
- Drugs
- somatropin
- Conditions
- cystinosis
01
Overview
Phase 2, randomised, open-label trial of somatropin in cystinosis (2 arms), sponsored by National Human Genome Research Institute. Primary endpoints: Increase in muscle mass at 12 months and Improve muscle strengths at 12 months. Planned start Mar 2014; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sequence A
GH for 12 months then No Treatment for 12 months
Sequence B
No Treatment for 12 months then GH for 12 months
03
Who it enrols
Adults with nephropathic cystinosis and muscle involvement who are compliant with cysteamine treatment and enrolled in protocol 78-HG-0093.
04
Endpoints
Primary
Increase in muscle mass
Improve muscle strengths
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