A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b

Zymenex A/S0 个研究点目标入组 9 人开始时间: 2012年1月18日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•The subject must have participated in the phase 1 trial (EudraCT number: 2010-022084-36) and phase 2a trial (EudraCT number: 2010-022085-26)
•Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
•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: 8
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The subject cannot walk without support
•Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-Mannosidosis
•History of bone marrow transplantation
•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
•Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial.
•Psychosis within the last 3 months
•Planned major surgery that, in the opinion of the investigator, would preclude participation in the trial
•Participation in other interventional trials testing IMP except for studies with Lamazym

发起方