The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Resolution of pseudo membrane associated with ligneous conjunctivitis
研究概览
简要总结
Allogenic plasma aliquots, used as eye drops, will provide a source of plasminogen in the treatment of ligneous conjunctivitis. The investigational product will be available through written request from the Sponsor-Investigator to Canadian Blood Services, as approved by Health Canada.
详细描述
Ligneous conjunctivitis is a chronic progressive disorder of the conjunctival mucosa which occurs secondary to plasminogen deficiency. The condition is characterized by thick, fibrous pseudo membranes adherent to the conjunctival surface of the eye lid.The investigational product, allogenic plasma aliquots, is a source of plasminogen. It will be used as eye drops, to treat recurrences of these pseudo membranes by providing the plasminogen required for fibrinolysis. The allogenic plasma aliquots are prepared by Canadian Blood Services. An initial supply of 680 vials was made available through the Special Access program, upon approval by Health Canada. Through this Clinical Trial, additional allogenic plasma aliquots will be available when required to treat recurrences of the pseudo membranes. The study has been conditionally approved by local HREB, pending registration with clinicaltrials.gov
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency
排除标准
- •Subject has concurrent eye disease which prevents use of the investigational drug
研究组 & 干预措施
Allogenic Plasma Aliquots
Allogenic Plasma Aliquots to be used as eye drops in the treatment of recurrences of ligneous conjunctivitis. Two drops will be administered to the affected eye, every 1 to 4 hours, depending on severity of the recurrence.
干预措施: Allogenic plasma aliquots, a source of plasminogen (Biological)
结局指标
主要结局
Resolution of pseudo membrane associated with ligneous conjunctivitis
时间窗: From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment
Patient to be observed daily to every few weeks for resolution, based on clinical observation
次要结局
未报告次要终点
研究者
Dorothy Bautista, MD
Clinical Professor
Memorial University of Newfoundland