NL-OMON55372招募中3 期
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 - Kamada-AAT (Inhaled)- 008
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Kamada Ltd.
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Double-Blind Period
- •1. Diagnosis of severe AAT deficiency, i.e. patients with either Pi(ZZ),
- •Pi(Z/Null), or Pi(Null/Null) genotypes confirmed by genotype blood test
- •documented prior to screening.
- •2. Serum AAT levels <= 11 µM at screening.
- •3. Lung disease with clinical evidence of airflow limitation (post
- •bronchodilator FEV1/SVC<=70%) at screening.
- •4. 40% <= FEV1 <= 80% of predicted post-bronchodilator at screening.
- •5. Patients who are either naïve or washed out of any AAT treatment for at
- •least 8 weeks prior to randomization.
- •6. Age between 18 to 65 years inclusive at screening.
- •7. Able to read and sign informed consent and willing to participate in the
- •8. Males or non-pregnant, non-lactating females whose screening pregnancy test
- •is negative, who are willing to use contraceptive methods for the duration of
- •the study, or who are postmenopausal, or surgically sterilized.
- •9. Study medication use for at least 20 out of the 28 days of run-in, as
- •recorded in the study nebulization PARI Track data.
- •10. Demonstrated ability to complete eDiary for at least 20 out of the first 28
- •days of run-in.
- •Open-Label Period
- •1. Patients who completed 104 weeks of DB study treatment and attended the end
- •of treatment visit.
- •2. Patients who completed the DB period and attended follow-up visits are
- •eligible for the OLE provided that they comply with all other OLE eligibility
- •3. Consenting to continue study participation in the OLE phase.
- •4. Agree to continue using contraceptive methods deemed reliable by the
- •investigator for an additional 2 years, unless post-menopausal or surgically
- •sterilized.
排除标准
- •Double-Blind Period
- •1. Immunoglobulin A (IgA) absolute deficiency defined as serum IgA levels< 0.05
- •2. History of life-threatening transfusion reaction(s), allergy, anaphylactic
- •reaction, or systemic response to human plasma-derived products.
- •3. Two or more moderate or any severe exacerbation(s) within the year prior to
- •4. A moderate exacerbation within 6 weeks prior to baseline.
- •5. Use of oral or parenteral glucocorticoids in doses above 10 mg of prednisone
- •daily or equivalent generics (substance and dose).
- •6. Clinically significant inter-current illnesses (except for respiratory or
- •liver disease secondary to AAT deficiency), including cardiac, hepatic, renal,
- •endocrine, neurological, hematological, neoplastic, immunological, skeletal, or
- •other. Patients might be included after consultation with the treating
- •physician and the sponsor if, in the opinion of the Investigator, their
- •condition will not interfere with the safety, compliance or other aspects of
- •this study.
- •7. Hospitalization for any cause 6 weeks prior to screening.
- •8. History of lung or liver transplant.
- •9. On any thoracic or hepatic surgery waiting list.
- •10. Any lung surgery within the past two years (including bronchoscopic lung
- •volume reduction).
- •11. Any smoking within the year prior to screening.
- •12. Evidence of alcohol abuse or history of alcohol abuse, or use of illegal
- •drugs and/or abuse of legally prescribed drugs in the last 5 years prior to
- •13. Acute or chronic hepatitis (hepatitis A, hepatitis B, hepatitis C), or
- •positive human immunodeficiency virus (HIV) serology.
- •14. Signs of significant abnormalities in serum hematology, serum chemistry,
- •serum inflammatory / immunogenic markers and urinalysis per investigator
- •judgment, taking into considerations the potential effects of the AAT
- •deficiency.
- •15. Signs of significant abnormalities in ECG per investigator judgment at
- •16. Presence of psychiatric/ mental disorder or any other medical disorder that
- •might impair the patient*s ability to give informed consent or to comply with
- •the requirements of the study protocol. If, in the opinion of the Investigator,
- •the condition will not interfere with the compliance or other aspects of this
- •study, the patient might be included after consultation with the treating
- •physician and the sponsor.
- •17. Participation in another clinical trial involving investigational
- •medication or interventional treatment within 30 days and/or last dose 5
- •half-lives prior to screening visit.
- •18. Inability to attend scheduled clinic visits and/or comply with study
- •19. Any other factor that, in the opinion of the investigator, would prevent
- •the patient from complying with the requirements of the protocol.
- •Open-Label Period
- •1. Any adverse event(s) in the DB period and/or medical condition that, in the
- •opinion of the investigator, might prevent the patient from safely
- •participating in the OLE period of the study, including but not limited to:
- •a. Occurrence of a life-threatening allergy, anaphylactic reaction, or systemic
- •response to human plasma derived products.
- •b. Received lung transplant, entered a waiting list for lung transplantation,
- •or underwent lung surgery. The investigator should consult the sponsor before
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