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Tetrathiomolybdate in refractory idiopathic pulmonary fibrosis
NCT00189176Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2003
- Primary completion
- May 2006
- Countries
- 1
- Sponsor
- University of Michigan
- Modality
- Small Molecules
- Drugs
- tetrathiomolybdate
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 2, open-label, single-arm trial of tetrathiomolybdate in idiopathic pulmonary fibrosis (IPF), sponsored by University of Michigan. Primary endpoint: Safety at 1 year. Started Mar 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Tetrathiomolybdate
Patients receive tetrathiomolybdate.
03
Who it enrols
Patients with IPF refractory to prior therapy (steroids +/- azathioprine/cyclophosphamide), age 35-80, with preserved hematologic and hepatic function. Excludes collagen vascular disease, active infection, significant cardiac disease, and poorly controlled diabetes.
04
Endpoints
Primary
Safety
Secondary
Change in pulmonary function
Change in exercise capacity
Change in quality of life
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