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No Longer AvailableNCT03172455

Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

Status
No Longer Available
Phase
—
Study type
Expanded Access
Enrollment
—
Sponsor
Impatients N.V. trading as myTomorrows · Industry
Sex
All
Age
—
Healthy volunteers
—

Summary

An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly diagnosed with acute GvHD.

Detailed description

GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI. Alpha-1 proteinase inhibitor belongs to the family of serine proteinase inhibitors and is primarily produced in the liver and secreted into the circulation. In addition to its anti-proteinase activity, A1PI showed to have anti-inflammatory, anti-apoptotic and immunomodulatory properties (1-4). GLASSIA is an injection solution prepared from human plasma collected from healthy volunteer blood donors in accordance with Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations. GLASSIA was approved in the United States (US) in July 2010 and is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).

Conditions

Interventions

TypeNameDescription
DRUGGlassiaApplication 90 mg/kg loading dose day 1, 30 mg/kg every other day (day 3 - day 15)

Timeline

First posted
2017-06-01
Last updated
2020-10-05

Source: ClinicalTrials.gov record NCT03172455. Inclusion in this directory is not an endorsement.