Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189176
• Other study ID #: 2002-0806
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 10, 2005
• Last updated: February 5, 2013
• Start date: March 2003
• Est. completion date: May 2006

Study information

• Verified date: February 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Tetrathiomolybdate

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Coalition for Pulmonary Fibrosis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		1 year	Yes