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Kamada-API

Phase 2

Alpha 1-Antitrypsin Deficiency | Small molecule | Rare Disease |Kamada Ltd.|Last Updated: Oct 17, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Kamada-API · 1 trial · 1 indication

Phase 2 1
NCT00460096Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin DeficiencyAlpha 1-Antitrypsin Deficiency
COMPLETED50 Analytics
PHASE2COMPLETED
Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
Alpha 1-Antitrypsin DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy

Secondary Endpoints

Safety
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Kamada-APIDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Signed informed consent. 2. "At-risk" alleles associated with serum AAT \< 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening. 3. At least 18 years of age. 4. Evidence of lung diseas...

Countries:United States
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Frequently asked questions about Kamada-API

What is Kamada-API used for?

Kamada-API is used for the treatment of Alpha 1-Antitrypsin Deficiency, a rare genetic condition that can lead to lung and liver damage. It is an investigational therapy being developed by Kamada Ltd. and is currently in Phase 2 clinical development.

Who makes Kamada-API?

Kamada-API is being developed by Kamada Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol KMDA. The drug is an investigational small molecule intended for patients with Alpha 1-Antitrypsin Deficiency.

What phase is Kamada-API in?

Kamada-API is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase II/III study of the drug has been completed, but it remains in clinical development for Alpha 1-Antitrypsin Deficiency.

What clinical trials is Kamada-API in?

Kamada-API has been studied in a completed clinical trial with the identifier NCT00460096. This was a Phase II/III study that enrolled 50 participants with Alpha 1-Antitrypsin Deficiency in the United States. The trial was randomized and double-blind, though it did not use a control group.

Is Kamada-API FDA approved?

Kamada-API is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alpha 1-Antitrypsin Deficiency. A Phase II/III clinical trial has been completed, but the drug has not yet received regulatory approval.