EUCTR2016-003403-66-SE进行中（未招募）1 期
An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-O
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who completed the SENSCIS/1199-0340 trial per protocol and did not permanently discontinue study 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 potential1 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 and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
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, any of the following
- •a. Known genetic predisposition to bleeding according to the judgement of the
- •investigator
- •b. Patients who require
- •i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
- •antagonists, direct thrombin inhibitors, heparin, hirudin)
- •ii. High dose antiplatelet therapy.
- •[Note: Prophylactic low dose heparin or heparin flush as needed for
- •maintenance of an indwelling intravenous device (e.g. enoxaparin 4000
- •I.U. s. c. per day), as well as prophylactic use of antiplatelet therapy (e.g.
- •acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or
- •equivalent doses of other antiplatelet therapy) are not prohibited].
- •c. Hemorrhagic central nervous system (CNS) event after completion of the
- •parent trial SENSCIS/1199-0340
- •d. Any of the following after last treatment of SENSCIS/1199-0340:
- •i. Haemoptysis or haematuria
- •ii. Active gastro-intestinal bleeding or GI – ulcers
- •iii. Gastric antral vascular ectasia (GAVE)
- •iv. Major injury or surgery (investigators judgement).
- •e. Coagulation parameters: International normalised ratio (INR) >2, prolongation
- •of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x
- •ULN at Visit 1.
- •6. New major thrombo-embolic events developed after completion of the parent trial
- •SENSCIS/1199-0340 :
- •b. Deep vein thrombosis;
- •c. Pulmonary embolism;
- •d. Myocardial infarction.
- •7. Major surgery (major according to the investigator’s assessment) performed within the
- •next 3 months
- •8. Time period > 12 weeks between last drug intake in SENSCIS or > 1 week between last nintedanib in trial 1199-0340 and Visit 2 of this trial.
- •9. Usage of any investigational drug after completion of the parent trial SENSCIS/1199-0340 or
- •planned usage of an investigational drug during the course of this trial.
- •10. A disease or condition which in the opinion of investigator may put the patient at risk
- •because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction)
- •or limit the patient’s ability to participate in this trial
- •11. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes
- •them an unreliable trial subject or unlikely to complete the trial
- •12. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
- •13. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- •14. Previous enrolment in this trial
研究者
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