Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT00189176
Last Updated: 2013-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2003-03-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tetrathiomolybdate
Tetrathiomolybdate
Interventions
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Tetrathiomolybdate
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
35 Years
80 Years
ALL
No
Sponsors
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Coalition for Pulmonary Fibrosis
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Kevin R. Flaherty
Associate Professor of Medicine
Principal Investigators
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Kevin R Flaherty, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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2002-0806
Identifier Type: -
Identifier Source: org_study_id