Status:
COMPLETED
Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Coalition for Pulmonary Fibrosis
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
35-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety of the administration of a copper chelating agent, tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous treatment. The prim...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic pulmonary fibrosis
- Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following:
- Increased symptoms
- Decline in forced vital capacity of at least 10%
- Decline in diffusion capacity for carbon monoxide of at least 20%
- Increased infiltrate on CXR or high resolution CT scan
- Taking \< 15 mg prednisone for at least 30 days prior to screening
- Age 35-80, inclusive
- Able to understand a written informed consent and comply with the study protocol
Exclusion
- Significant environmental exposure
- Diagnosis of collagen vascular disease
- Evidence of active infection
- Clinically significant cardiac disease:
- Myocardial infarction, coronary artery bypass or angioplasty within 6mo
- Unstable angina pectoris
- Congestive heart failure requiring hospitalization within 6 months
- Uncontrolled arrhythmia
- Poorly controlled or severe diabetes mellitus
- Pregnancy or lactation
- Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
- Current enrollment in another experimental protocol
- Physiologic Criteria:
- FEV1/FVC \< 0.60
- Laboratory Criteria:
- Total bilirubin \> 1.5 X upper limit normal
- AST or ALT \> 3X upper limit normal
- Alkaline phosphatase \> 3X upper limit normal
- White blood cell count \< 2,500/mm3
- Hematocrit \< 30%
- Platelets \< 100,000/mm3
- Prothrombin time INR \> 1.5
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00189176
Start Date
March 1 2003
End Date
May 1 2006
Last Update
February 6 2013
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109