A multi-center, un-controlled, open-labeled trial of the long-term safety of Velmanase Alfa aftercaretreatment of subjects with alpha-Mannosidosis whom previously participated in Velmanase Alfa - trials - Phase IIIb

Chiesi Farmaceutici S.p.A.0 个研究点目标入组 8 人开始时间: 2013年6月7日最近更新: 2023年1月9日

试验速览

暂无简介。

•1.The subject must have participated in previous Velmanase- Alfa -trials: phase 2b: 2011-004355-40, phase 3: 2012-000979-17 or phase 2 2016-001988-36
•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: 5
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3
•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 woman is excluded. Before start of the treatment the investigators will for women of childbearing potential perform a pregnancy test and evaluate with the patients and/or parents 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.

发起方