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Kamada Ltd.

首页临床试验发起方与机构Kamada Ltd.

Kamada Ltd.

ACTIVE

以色列www.kamada.comPublic378 名员工成立于: 1990-01-01

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相关临床试验

8

6 进行中

药物批准

4

批准总数

监管机构

1

监管机构数

成立时间

1990

概览

试验阶段分布

阶段

试验数

占比

1 期

6

75.0%

3 期

2

25.0%

试验状态分布

进行中（未招募）

6

75.0%

招募中

2

25.0%

相关临床试验

该机构主办的试验（8）

A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% = FEV1 = 80% of predicted; FEV1/SVC = 70%).

进行中（未招募）

Jun 2020220 名受试者

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% = FEV1 = 80% of predicted; FEV1/SVC = 70%), Followed by a 2-Year Open-Label Extension.

进行中（未招募）

May 2020220 名受试者

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% = FEV1 = 80% of predicted; FEV1/SVC = 70%), Followed by a 2-Year Open-Label Extensio

进行中（未招募）

Apr 2020220 名受试者

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% = FEV1 = 80% of predicted; FEV1/SVC = 70%), Followed by a 2-Year Open-Label Extensio

进行中（未招募）

Mar 2020220 名受试者

A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%).

进行中（未招募）

Mar 2020220 名受试者

A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% = FEV1 = 80% of predicted; FEV1/SVC = 70%).

进行中（未招募）

May 2019220 名受试者

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), Followed by a 2-Year Open-Label Extension

108 名受试者

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% <= FEV1 <= 80% of predicted; FEV1/SVC <= 70%), Followed by a 2-Year Open-Label Extensio

70 名受试者

药物批准

按机构分类的批准

FDA

Food and Drug Administration

4

药物批准

近期批准

资讯

Kamada Receives FDA Approval for In-House Rabies Virus Neutralization Testing Laboratory

- Kamada Ltd. announced FDA approval of its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory, the gold standard for measuring rabies-neutralizing antibodies. - The new laboratory will support quality control testing for KEDRAB and KAMRAB manufacturing, representing over $70 million in sales for 2025. - The facility enables increased operational efficiencies and reduces reliance on external testing while meeting stringent safety, quality and GMP standards. - The laboratory is located in Kamada's Beit Kama, Israel plant and is one of a limited number of facilities worldwide capable of performing such specialized tests.

Kamada Secures FDA Approval for San Antonio Plasma Collection Center, Expanding Specialty Plasma Production Capacity

- Kamada Ltd. received FDA approval for its San Antonio plasma collection center following a February 2026 inspection, clearing the facility to commence commercial sales of normal source plasma. - The 11,100 square foot facility supports up to 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenues of $8-10 million at full capacity. - The center is designed to collect both normal source plasma and specialty plasma including anti-rabies and anti-D products, positioning it as one of the largest specialty plasma collection centers in the United States. - Kamada now operates three FDA-approved plasma collection centers in Texas, significantly expanding its capacity for specialty and normal source plasma collection to support its portfolio of rare disease treatments.

Kamada Receives FDA Approval for Houston Plasma Collection Center, Expanding Specialty Plasma Operations

- Kamada Ltd. received FDA approval for its Houston plasma collection center following a second quarter 2025 inspection, clearing the facility to commence commercial sales of normal source plasma. - The 12,000 square foot facility features 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenue contribution of $8-10 million at full capacity. - The Houston center is anticipated to become one of the largest specialty plasma collection sites in the U.S., collecting both normal source plasma and specialty plasma including anti-rabies and anti-D products. - Combined with existing facilities in Beaumont and San Antonio, Texas, Kamada now operates three plasma collection centers to support its portfolio of FDA-approved plasma-derived therapies for rare conditions.

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相关临床试验8
药物批准4
资讯3

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