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NCT Number: NCT00189176

Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetrathiomolybdate

Drug

Primary outcomes

  1. Safety

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Coalition for Pulmonary Fibrosis

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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