Trials / Terminated
TerminatedNCT01530256
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALD518 | 160 mg IV q 4 weeks for 4 doses |
| BIOLOGICAL | ALD518 | 320 mg IV q 4 weeks for 4 doses |
| BIOLOGICAL | ALD518 | 640 mg IV q 4 weeks for 2 doses |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2012-02-09
- Last updated
- 2021-02-17
- Results posted
- 2021-02-17
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01530256. Inclusion in this directory is not an endorsement.