Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Coalition for Pulmonary Fibrosis
Information provided by (Responsible Party):
Kevin R. Flaherty, University of Michigan
ClinicalTrials.gov Identifier:
NCT00189176
First received: September 10, 2005
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Tetrathiomolybdate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: March 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tetrathiomolybdate Drug: Tetrathiomolybdate

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189176

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Coalition for Pulmonary Fibrosis
Investigators
Principal Investigator: Kevin R Flaherty, MD, MS University of Michigan
  More Information

No publications provided

Responsible Party: Kevin R. Flaherty, Associate Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00189176     History of Changes
Other Study ID Numbers: 2002-0806
Study First Received: September 10, 2005
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Tetrathiomolybdate
Molybdenum
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Trace Elements
Micronutrients

ClinicalTrials.gov processed this record on October 19, 2014