Trials / Terminated
TerminatedNCT02956122
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal Involvement
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GLASSIA | GLASSIA \[Alpha1-Proteinase Inhibitor (Human)\] |
| DRUG | methylprednisolone or equivalent steroid | The conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice. |
| BIOLOGICAL | Albumin | The control vials contain human albumin 20% in 50 mL normal saline solution in glass vials (for non-United States (US) Countries), or Flexbumin 25% in 50 mL in normal saline solution in plastic IV bags (for US). |
Timeline
- Start date
- 2017-04-26
- Primary completion
- 2018-05-03
- Completion
- 2018-05-03
- First posted
- 2016-11-07
- Last updated
- 2021-01-13
- Results posted
- 2019-04-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02956122. Inclusion in this directory is not an endorsement.