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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03172455
Expanded Access Status : No longer available
First Posted : June 1, 2017
Last Update Posted : October 5, 2020
Kamada, Ltd.
Information provided by (Responsible Party):
Impatients N.V. trading as myTomorrows

Brief 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.

Condition or disease Intervention/treatment
Acute-graft-versus-host Disease Steroid Refractory Acute Graft Versus Host Disease Graft-versus-host-disease Graft Vs Host Disease Alpha 1-Antitrypsin Deficiency Alpha-1 Proteinase Inhibitor Alpha-1 Protease Inhibitor Deficiency Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant Drug: Glassia

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).

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Study Type : Expanded Access
Official Title: Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

Intervention Details:
  • Drug: Glassia
    Application 90 mg/kg loading dose day 1, 30 mg/kg every other day (day 3 - day 15)
    Other Name: Alpha 1 antitrypsin

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • This program is available for patients who suffer from steroid refractory acute GvHD after HSCT, or for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
  • The disease indication for which the participant required HSCT must be in remission
  • Acute graft-versus-host disease (aGvHD), including lower GI involvement (modified
  • International Bone Marrow Transplant Registry (IBMTR) Severity Stage 1 to 4 [>500 mL diarrhea/day]), with or without other organ system involvement.
  • For women of childbearing potential, had a negative serum or urine pregnancy test within 14 days prior to enrolment.

Exclusion Criteria:

  • Participant with manifestations of chronic GvHD
  • Participant with acute/chronic GvHD overlap syndrome
  • Participant whose GvHD developed after donor lymphocyte infusion
  • Participant with severe sepsis involving at least 1 organ failure
  • Participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (HIV)
  • Participant with active hepatitis B or C
  • If female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the program

No Contacts or Locations Provided
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Responsible Party: Impatients N.V. trading as myTomorrows Identifier: NCT03172455    
Other Study ID Numbers: 2017-AATGLAKAM-EU
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Graft vs Host Disease
Immune System Diseases
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action