Respiratory Distress Syndrome, AdultPhase 1/2NCT00029328
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
A Phase 1/2 study testing etanercept in people with Respiratory Distress Syndrome, Adult and Bronchiolitis Obliterans, run by FDA Office of Orphan Products Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans, Pneumonia
- What is being tested?
- etanercept
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
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.
Read the detailed description
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.
- Being tested
- etanercept
- Keywords
- TNFR-Fc fusion protein, Stem Cell Transplantation, Transplantation, Homologous, Respiratory Function Tests
- Medical subject headings
- Respiratory Distress Syndrome, Bronchiolitis Obliterans, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2002 (estimated)
- Study startSep 2001
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Investigators
- Kenneth Cooke, M.D., Principal investigator, University of Michigan, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029328
- Sponsor's protocol ID
- FD-R-2020-01
- Other IDs
- UMCC-0078;, FD-R-002020-01
- Status last verified
- Nov 2001
- First submitted
- 10 Jan 2002
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00029328
- Acronym / sponsor ID
- FD-R-2020-01
- Keywords
- TNFR-Fc fusion protein, Stem Cell Transplantation, Transplantation, Homologous, Respiratory Function Tests
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Study start
- Sep 2001
- Study completion
- Sep 2003
- First posted
- 11 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanercept | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Cooke, M.D. principal investigator
University of Michigan, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing etanercept in people with Respiratory Distress Syndrome, Adult and Bronchiolitis Obliterans, run by FDA Office of Orphan Products Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.