NCT01908725已完成3 期
A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change from baseline in Adverse events
研究概览
简要总结
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.
详细描述
This protocol only concern subjects where compassionate use program was not accepted. Efficacy will be evaluated once yearly to follow the subject's progress in clinical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
- •Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
- •The subject and his/her guardian(s) must have the ability to comply with the protocol
排除标准
- •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 circumstances that, in the opinion of the Investigator, would preclude participation in the trial
- •Pregnancy. Pregnant woman is excluded. Before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
- •Psychosis; any psychotic disease, also in remission, is an exclusion criteria
- •Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
研究组 & 干预措施
Lamazym
Experimental
1 mg Lamazym/kg body weight
干预措施: Lamazym (Drug)
结局指标
主要结局
Change from baseline in Adverse events
时间窗: 3 year
AE documented at all visits
Change from baseline in Lamazym antibodies
时间窗: 3 year
AB measured every 12th week
次要结局
- progress from baseline in number of steps climbed in 3 minutes(1 year, 2 year and 3 year)
- Progress from baseline in equivalent age(1 year, 2 year and 3 year)
- Progress from baseline in Forced Vital Capacity(1 year, 2 year and 3 year)
- Progress from baseline in distance walked in 6 minutes(1 year, 2 year and 3 year)
研究者
研究点 (1)
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