A multi-center, un-controlled, open-labeled trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis

Chiesi Farmaceutici S.p.A.0 个研究点目标入组 13 人开始时间: 2014年12月3日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•1. The subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
•2. Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
•3. The subject and his/her guardian(s) must have the ability to comply with the protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
•2. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
•3. Pregnancy: Pregnant women are excluded. Before start of the treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
•4. Psychosis; any psychotic disease, also in remission, is an exclusion criteria
•5. Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
•6. Adult patients who, in the opinion of the investigator, would be unable to give consent, and who does not have any legal protection or guardianship
•7. Total IgE >800 IU/mL
•8. Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)

发起方