NCT00029328

Brief Summary

The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

March 25, 2015

Status Verified

November 1, 2001

First QC Date

January 10, 2002

Last Update Submit

March 24, 2015

Conditions

Respiratory Distress Syndrome, AdultBronchiolitis ObliteransPneumonia

Keywords

TNFR-Fc fusion proteinStem Cell TransplantationTransplantation, HomologousRespiratory Function Tests

Interventions

etanerceptDRUG

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
  • At least 1 year of age for IPS stratum
  • At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
  • At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
  • Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

You may not qualify if:

  • Documented evidence of active systemic or pulmonary infection
  • Cardiogenic failure as cause of pulmonary dysfunction
  • Known hypersensitivity to etanercept
  • Currently receiving dialysis
  • Currently receiving inotropic medications except dopamine
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeBronchiolitis ObliteransPneumonia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersBronchiolitisBronchitisBronchial DiseasesLung Diseases, ObstructiveRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Kenneth Cooke, M.D.

    University of Michigan, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

January 10, 2002

First Posted

January 11, 2002

Study Start

September 1, 2001

Study Completion

September 1, 2003

Last Updated

March 25, 2015

Record last verified: 2001-11

Locations

US(1)