Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy
1 other identifier
interventional
23
1 country
1
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 primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2003
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFebruary 6, 2013
February 1, 2013
3.2 years
September 10, 2005
February 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
1 year
Study Arms (1)
Tetrathiomolybdate
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Coalition for Pulmonary Fibrosiscollaborator
Study Sites (1)
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin R Flaherty, MD, MS
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 16, 2005
Study Start
March 1, 2003
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
February 6, 2013
Record last verified: 2013-02