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Kamada AAT for

Phase 2

Emphysema | Monoclonal antibody | Respiratory |Kamada Ltd.|Last Updated: Nov 29, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

Kamada AAT for · 1 trial · 1 indication

Phase 2 1
NCT01217671International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With EmphysemaEmphysema
COMPLETED168 Analytics
PHASE2COMPLETED
International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema
EmphysemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Exacerbation events and lung density
Approximately 1 year

Secondary Endpoints

Adverse Events
Approximately 1 year
Vital Signs
Approximately 1 year
Physical Examination
Approximately 1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Alpha-1 AntitrypsinEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Kamada AAT for inhalationBIOLOGICALAlpha-1 Antitrypsin (AAT)
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Principal Inclusion Criteria: * Diagnosis of emphysema confirmed by CT scan. If a report of past CT scan is not available at site documenting then a CT scan is to be performed at screening * Male or female patients at least 18 years of age. * Able and willing to sign an informed consent. * Patient ...

Countries:CanadaDenmarkGermanyIrelandNetherlandsSwedenUnited Kingdom
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Frequently asked questions about Kamada AAT for

What is Kamada AAT for?

Kamada AAT for is an inhaled, human, alpha-1 antitrypsin (AAT) therapy in Phase 2 clinical development for the treatment of Alpha-1 Antitrypsin Deficiency and emphysema. It is being developed by Kamada Ltd. (KMDA) as a respiratory therapeutic. The drug is administered via inhalation to deliver AAT directly to the lungs.

What does Kamada AAT for target?

Kamada AAT for is a monoclonal antibody that targets alpha-1 antitrypsin deficiency, a genetic condition that leads to low levels of the AAT protein, which protects the lungs from damage. By delivering inhaled human AAT, the therapy aims to supplement the deficient protein and potentially slow the progression of emphysema associated with the condition.

Who makes Kamada AAT for?

Kamada AAT for is developed by Kamada Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KMDA. The company specializes in plasma-derived therapies and is conducting clinical trials to evaluate the safety and efficacy of this inhaled AAT product for patients with Alpha-1 Antitrypsin Deficiency and emphysema.

What phase is Kamada AAT for in?

Kamada AAT for is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, with a total enrollment of 204 patients across studies in multiple countries, including the United States, Canada, and several European nations.

What clinical trials is Kamada AAT for in?

Kamada AAT for has been studied in two completed Phase 2 clinical trials. The first, NCT01217671, enrolled 168 patients with emphysema across Canada, Denmark, Germany, Ireland, Netherlands, Sweden, and the United Kingdom. The second, NCT02001688, enrolled 36 patients with Alpha-1 Antitrypsin Deficiency in the United States. Both trials were randomized, double-blind, and placebo-controlled.

Is Kamada AAT for the same as Kamada-alpha-1-antitrypsin?

Yes, Kamada AAT for is the same drug as Kamada-alpha-1-antitrypsin (AAT) for inhalation. The clinical trial NCT02001688 refers to the drug as Kamada-alpha-1-antitrypsin (AAT) for inhalation, while the product is commonly known as Kamada AAT for. Both names refer to the same inhaled human AAT therapy under development by Kamada Ltd.