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NCT01163786 · ClinicalTrials.gov registry record · Phase 2
A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01163786 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 17 participants.
The verdict
NCT01163786, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common late noninfectious complication following allogeneic hematopoietic stem cell transplant. Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent obstructive airways disease and viral infections1. BO is characterized physiologically by progressive irreversible airflow obstruction and pathologically by luminal occlusion of the distal airways due to progressive scarring3. The pathogenesis is not completely understood but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with other data in the literature that proteasomal inhibition can prevent the development of fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of bortezomib in chronic pulmonary GVHD (BO).
Interventions
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-10-07 |
| Est. Completion | 2015-09-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01163786
The ClinicalTrials.gov registry entry for NCT01163786 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bortezomib is the first listed.
NCT01163786 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01163786 about?
NCT01163786 is a clinical study titled "A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD". Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common late noninfectious complication following allogeneic hematopoietic stem cell transplant. Prognosis of BO in the alloge...
What is the current status of trial NCT01163786?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-10-07. Estimated completion is 2015-09-09.
What interventions are being tested in trial NCT01163786?
The interventions under investigation include: Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01163786?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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