CTRI/2018/03/012529尚未招募3 期
An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD)
Boehringer Ingelheim India Pvt Ltd9 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年1月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- The primary endpoint is the incidence (number and % of patients) of overall adverse events
研究概览
简要总结
This is an open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).
The primary objective of this trial is to assess the long-term safety of nintedanib treatment in patients with Systemic Sclerosis associated Interstitial Lung Disease who have completed (did not prematurely
discontinue trial medication) the phase III parent trial SENSCISTM (1199.214).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment.
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.
- •A list of contraception methods meeting these criteria is provided in the patient information.
排除标准
- •AST, ALT > 3 x ULN
- •Bilirubin > 2 x ULN
- •Creatinine clearance <30 mL/min
- •Clinically relevant anaemia at investigators discretion.
- •Bleeding risk, like a.
- •Known genetic predisposition to bleeding as per investigator b.
- •Patients who require -Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vit K antagonists,DTI, heparin, hirudin) -High dose antiplatelet therapy.
- •Hemorrhagic CNS event after completion of main study 6.Any of the following after last treatment of the parent trial -Haemoptysis or haematuria -Active GI bleeding or GI – ulcers -Major injury or surgery (PI judgement) 7.Coagulation parameters: INR >2, prolongation of PT & PTT by >1.5 x ULN at Visit 1
- •New major thrombo-embolic events developed after completion of the parent trial: -Stroke -DVT -PE -MI 9.Major injury or surgery (major according to the investigator’s assessment) done within the next 3 months
- •Time period > 12 weeks between last drug intake of the parent trial SENSCISTM & randomization visit of this study
- •A disease or condition which in the opinion of investigator may put the patient at risk.
结局指标
主要结局
The primary endpoint is the incidence (number and % of patients) of overall adverse events
时间窗: Endpoint Assessment through out the course of the study. Final Assessment at the end of the study.
over the course of this extension trial.
时间窗: Endpoint Assessment through out the course of the study. Final Assessment at the end of the study.
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (9)
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