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 â??Systemic Sclerosis associatedInterstitial Lung Diseaseâ?? (SSc-ILD) - SENSCISTM- ON (Extension)
Boehringer Ingelheim India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment.
- •2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •3. 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
- •1. AST, ALT > 3 x ULN
- •2. Bilirubin > 2 x ULN
- •3. Creatinine clearance <30 mL/min
- •4. Clinically relevant anaemia at investigators discretion.
- •5. 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 â?? ulcers
- •-Major injury or surgery (PI judgement)
- •7.Coagulation parameters: INR >2, prolongation of PT & PTT by >1.5 x ULN at Visit 1
- •8. New major thrombo-embolic events developed after completion of the parent trial:
- •9.Major injury or surgery (major according to the investigatorâ??s assessment) done within the next 3 months
- •10. Time period > 12 weeks between last drug intake of the parent trial SENSCISTM & randomization visit of this study
- •11. A disease or condition which in the opinion of investigator may put the patient at risk.
研究者
相似试验
进行中（未招募）
1 期
A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.EUCTR2016-003403-66-NLBoehringer Ingelheim bv250
进行中（未招募）
1 期
A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.Systemic Sclerosis associated Interstitial Lung DiseaseMedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 21.0Level: LLTClassification code 10036814Term: Progressive systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: PTClassification code 10042954Term: Systemic sclerosis pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859EUCTR2016-003403-66-SEBoehringer Ingelheim AB400
进行中（未招募）
1 期
A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.Systemic Sclerosis associated Interstitial Lung DiseaseMedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 21.0Level: LLTClassification code 10036814Term: Progressive systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: PTClassification code 10042954Term: Systemic sclerosis pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859EUCTR2016-003403-66-GRBoehringer Ingelheim B.V400
进行中（未招募）
1 期
A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.Systemic Sclerosis associated Interstitial Lung DiseaseMedDRA version: 21.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 21.0Level: LLTClassification code 10036814Term: Progressive systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: PTClassification code 10042954Term: Systemic sclerosis pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2016-003403-66-ITBOEHRINGER-INGELHEIM ITALIA S.P.A.250
进行中（未招募）
1 期
A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.Systemic Sclerosis associated Interstitial Lung DiseaseMedDRA version: 20.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10036814Term: Progressive systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: PTClassification code 10042954Term: Systemic sclerosis pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859EUCTR2016-003403-66-FIBoehringer Ingelheim Fnland Ky444