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GLASSIA and Institution standard of care

Phase 2

Transplantation, Lung Rejection | Small molecule | Immunology |Kamada Ltd.|Last Updated: Sep 1, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

GLASSIA and Institution standard of care · 1 trial · 1 indication

Phase 2 1
NCT02614872Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung TransplantationTransplantation, Lung Rejection
COMPLETED30 Analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation
Transplantation, Lung RejectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of subjects experiencing AEs and/or SAEs
during the study

Incidence of subjects experiencing causally related AEs and/or SAEs

Incidence and rate of Acute Rejection
per year

Secondary Endpoints

Annual rate (per subject) of pulmonary infections
per year
Incidence of subjects who develop Bronchiolitis Obliterans
during the study
Changes in Pulmonary Function Test
Change from baseline and overall effect
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLASSIA®EXPERIMENTALGlassia® IV treatment additional to Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion.
Institution standard of care (SOC)NO_INTERVENTIONInstitution standard of care (SOC) for first lung transplant subjects according to Investigator discretion.

Interventions

NameTypeDescription
GLASSIA® and Institution standard of care (SOC)DRUGAlpha-1 Antitrypsin (AAT) \[GLASSIA®\] add-on pharmacotherapy and Institution standard of care (SOC)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed and dated informed consent. 2. Age ≥18 years. 3. Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure. Exclusion Criteria: 1. Subject has immunoglobulin A (IgA) deficiency and kn...

Countries:Israel
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Frequently asked questions about GLASSIA and Institution standard of care

What is GLASSIA used for in lung transplantation?

GLASSIA is being studied for use in lung transplantation to address lung rejection. A Phase 2 clinical trial evaluated the safety and efficacy of intravenous GLASSIA treatment in lung transplant patients. The study enrolled 30 participants in Israel and has been completed.

Who makes GLASSIA?

GLASSIA is developed by Kamada Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KMDA. The company conducted a Phase 2 clinical trial of GLASSIA for lung transplantation and lung rejection.

What phase is GLASSIA in for lung rejection?

GLASSIA is in Phase 2 clinical development for lung rejection in the context of lung transplantation. A single Phase 2 trial, NCT02614872, has been completed. The drug remains investigational and is not approved for this indication.

What clinical trials is GLASSIA in?

GLASSIA has one completed clinical trial, NCT02614872, titled 'Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation.' This Phase 2 study enrolled 30 participants aged 18 years and older in Israel and was not double-blinded.

Is GLASSIA the same as Glassia?

Yes, GLASSIA and Glassia refer to the same drug product. The clinical trial NCT02614872 uses the name 'Glassia®' in its title, while the drug is commonly referred to as GLASSIA. Both names denote the same investigational treatment for lung rejection.