AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EX

Savara ApS0 个研究点目标入组 90 人开始时间: 2018年2月1日最近更新: 2019年6月30日

研究概览

暂无简介。

•1. Completer of the IMPALA trial
•2. Females who have been post-menopausal for >1 year, or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with <1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence), during and until 30 days after last dose of trial treatment. Females of childbearing potential must have a negative urine pregnancy test at Baseline or at start of treatment if treatment is not dispensed at Baseline, and must not be lactating during and until 30 days after last dose of trial treatment.
•3. Males agreeing to use condoms during and until 30 days after last dose of trial treatment, or males having a female partner who is using adequate contraception as described above.
•4. Willing and able to provide signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Treatment with GM-CSF products other than molgramostim nebuliser solution within three months of Baseline.
•2. Treatment with any IMP other than inhaled molgramostim within four weeks of Baseline.
•3. History of allergic reactions to GM-CSF.
•4. Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone.
•5. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product.
•6. History of, or present, myeloproliferative disease or leukaemia.
•7. Apparent pre-existing concurrent pulmonary fibrosis.
•8. Any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial.

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