Transplantation, Lung RejectionPhase 2NCT02614872
Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation
A Phase 2 study of Transplantation, Lung Rejection, run by Kamada, Ltd. at 1 site in Israel.
Trial summary
This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Lung Rejection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Jul 2016to 7 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- Age ≥18 years.
- Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure.
Who cannot join
- Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies.
- Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) Type 1/2 infection
- Subjects with a history of severe immediate hypersensitivity reactions, including allergies, anaphylaxis to plasma products or any human proteins of different source.
- Pregnant or lactating women at entry to study and women of child bearing potential, who are unwilling to agree to continue to use acceptable methods of contraception throughout the study.
- Presence of psychiatric/ mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.
- Alcohol abuse or history of alcohol abuse.
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- Illegal drugs.
- Candidate for organ transplantation other than first lung or heart-lung transplantation
- Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
- Participation in another interventional clinical trial within 30 days prior to baseline visit.
- Inability to attend scheduled clinic visits and/or comply with the study protocol.
- Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept (POC) Study, Phase II, Open Label, Randomized, Standard Care - Controlled, Single Center Study Evaluating the Safety and Efficacy of Human, Alpha-1 Antitrypsin (AAT) [GLASSIA®] Treatment in First Lung Transplantation
This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.
Read the detailed description
There is clinical rationale to advocate the use of AAT(GLASSIA) therapy during episodes of lung inflammation, including acute and chronic rejection. AAT may provide more specifically targeted prevention of pathogenic inflammation, superior to that of general immunosuppressants, with little risk. AAT is the main inhibitor of Neutrophil elastase(NE) in the lower airways and patients with AAT deficiency have low concentrations of the protein in this region of the lung. This explains the proteinase/antiproteinase theory of the development of emphysema in deficient patients in which the amount of elastase released in the lung exceeds the amount of AAT. The net result is persistence of elastase activity leading to lung destruction and the pathological changes of emphysema. Administration of AAT will help to prevent further destruction of the lung architecture and reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that by attacking a specific and previously untreated key component of the pathophysiological cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients and prolong life expectancy of these patients. This will be an open label study in order to ensure safety, in the frame of POC study.
- Conditions
- Transplantation, Lung Rejection
- Being tested
- GLASSIA® and Institution standard of care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLASSIA® and Institution standard of care (SOC)Drug
Also called GLASSIA and Institution standard of care (SOC)
Alpha-1 Antitrypsin (AAT) [GLASSIA®] add-on pharmacotherapy and Institution standard of care (SOC)
| Study group | Role | What they receive |
|---|---|---|
| GLASSIA® | Experimental | Glassia® IV treatment additional to Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. Receives: Drug: GLASSIA® and Institution standard of care (SOC) |
| Institution standard of care (SOC) | No intervention | Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects experiencing AEs and/or SAEs
Incidence of subjects experiencing causally related AEs and/or SAEs
Measured: during the study
Incidence and rate of Acute Rejection
Incidence and rate of Acute Rejection
Measured: per year
Secondary outcomes (3)
Annual rate (per subject) of pulmonary infections
Annual rate (per subject) of pulmonary infections
Measured: per year
Incidence of subjects who develop Bronchiolitis Obliterans
Incidence of subjects who develop Bronchiolitis Obliterans
Measured: during the study
Changes in Pulmonary Function Test
Changes in Pulmonary Function Test
Measured: Change from baseline and overall effect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start26 Jul 2016
- Primary completion11 Apr 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, Lung RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mordechai Kramer, MD, Principal investigator, Pulmonary institute, Rabin Medical Center, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614872
- Sponsor's protocol ID
- CT2-LUNG-IV-IL-014
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2015
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept (POC) Study, Phase II, Open Label, Randomized, Standard Care - Controlled, Single Center Study Evaluating the Safety and Efficacy of Human, Alpha-1 Antitrypsin (AAT) [GLASSIA®] Treatment in First Lung Transplantation
- ClinicalTrials.gov ID
- NCT02614872
- Acronym / sponsor ID
- CT2-LUNG-IV-IL-014
- Conditions
- Transplantation, Lung Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.
Detailed description
There is clinical rationale to advocate the use of AAT(GLASSIA) therapy during episodes of lung inflammation, including acute and chronic rejection. AAT may provide more specifically targeted prevention of pathogenic inflammation, superior to that of general immunosuppressants, with little risk. AAT is the main inhibitor of Neutrophil elastase(NE) in the lower airways and patients with AAT deficiency have low concentrations of the protein in this region of the lung. This explains the proteinase/antiproteinase theory of the development of emphysema in deficient patients in which the amount of elastase released in the lung exceeds the amount of AAT. The net result is persistence of elastase activity leading to lung destruction and the pathological changes of emphysema. Administration of AAT will help to prevent further destruction of the lung architecture and reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that by attacking a specific and previously untreated key component of the pathophysiological cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients and prolong life expectancy of these patients. This will be an open label study in order to ensure safety, in the frame of POC study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLASSIA® | Experimental | Drug: GLASSIA® and Institution standard of care (SOC)Glassia® IV treatment additional to Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. |
| Institution standard of care (SOC) | No intervention | –Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent.
- Age ≥18 years.
- Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure.
Key exclusion criteria (12 listed)
- Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies.
- Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) Type 1/2 infection
- Subjects with a history of severe immediate hypersensitivity reactions, including allergies, anaphylaxis to plasma products or any human proteins of different source.
- Pregnant or lactating women at entry to study and women of child bearing potential, who are unwilling to agree to continue to use acceptable methods of contraception throughout the study.
- Presence of psychiatric/ mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLASSIA® and Institution standard of care (SOC)Also: GLASSIA and Institution standard of care (SOC)Alpha-1 Antitrypsin (AAT) [GLASSIA®] add-on pharmacotherapy and Institution standard of care (SOC) | Drug | GLASSIA® |
Primary outcome
Incidence of subjects experiencing AEs and/or SAEs
Time frame: during the study
Incidence of subjects experiencing causally related AEs and/or SAEs
Incidence and rate of Acute Rejection
Time frame: per year
Incidence and rate of Acute Rejection
3 secondary outcomes
Annual rate (per subject) of pulmonary infections
Time frame: per year
Incidence of subjects who develop Bronchiolitis Obliterans
Time frame: during the study
Changes in Pulmonary Function Test
Time frame: Change from baseline and overall effect
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordechai Kramer, MD principal investigator
Pulmonary institute, Rabin Medical Center, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Transplantation, Lung Rejection, run by Kamada, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subjects experiencing AEs and/or SAEs (time frame: during the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.