Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

University of Michigan

Status and phase

Completed

Phase 2

Phase 1

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Tetrathiomolybdate

Study type

Interventional

Funder types

Other

Identifiers

NCT00189176

2002-0806

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

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