ACTRN12605000010695招募中1 期
Multi Centre, Phase Ib Safety Study of anti-fibrin humanised monoclonal antibody (DI-DD3B6/22-80B3) Fab' Protein Fragment (ThromboView) conjugated with Technetium-99m in the Detection of Pulmonary Emboli
AGEN Biomedical Ltd0 个研究点目标入组 14 人开始时间: 2005年7月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Ability to sign informed consent; Onset of most recent episode of symptoms of PE occurring within 7 days of enrolment; Positive diagnosis of PE by CTPA performed in last 72 hours; Women of child-bearing potential to have negative serum pregnancy test at time of enrolment. Both male and female participants agree to use effective contraception for first thirty (30) days of study participation.
排除标准
- •Previously documented PE; Unable to undergo required imaging protocol; Prior exposure to murine/ chimeric/ humanized antibodies; Therapeutic anticoagulation for more than 72 hours prior to ThromboView administration; Thrombolytic therapy during current presentation; Renal dysfunction (serum creatinine >1.5 x ULN), renal transplant; Hepatic Dysfunction (serum transaminases > 3 x ULN); Primary or metastatic malignancies lungs/ pleura; Diffuse active inflammatory/ infectious pulmonary conditions involving > 2 lung segments; Life expectancy < 90 days; Geographic inaccessibility precluding follow up visits; Prior nuclear medicine imaging studies with radiolabelled isotopes (within relative time decay windows); Current pregnancy or lactation or conception intended within 3 months of enrolment and likely inability to gain IV Access.
研究者
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