Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
Coalition for Pulmonary Fibrosis
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00189176
First received: September 10, 2005
Last updated: December 2, 2005
Last verified: October 2005
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Purpose
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 primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis |
Drug: Tetrathiomolybdate |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Eligibility
Ages Eligible for Study: | 35 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189176
Locations
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109 |
Sponsors and Collaborators
University of Michigan
Coalition for Pulmonary Fibrosis
Investigators
Principal Investigator: | Kevin R Flaherty, MD, MS | University of Michigan |
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00189176 History of Changes |
Other Study ID Numbers: | 2002-0806 |
Study First Received: | September 10, 2005 |
Last Updated: | December 2, 2005 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Fibrosis Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pathologic Processes Lung Diseases Respiratory Tract Diseases Tetrathiomolybdate Molybdenum Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses Chelating Agents Trace Elements Micronutrients |
ClinicalTrials.gov processed this record on October 16, 2012