Trial | NCT00189176  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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.
Study Started
Mar 31
2003
Primary Completion
May 31
2006
Study Completion
May 31
2006
Last Update
Feb 06
2013
Estimate

Drug Tetrathiomolybdate

Tetrathiomolybdate Experimental

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
No Results Posted