NCT00514683已完成2 期
A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 92
- 主要终点
- Rate of Decline in FVC
研究概览
简要总结
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.
The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).
As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient >40 years
- •Written informed consent signed prior to entry into the study
- •IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
- •HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
- •FVC>50 % of predicted value
- •Predicted normal values will be calculated according to ESCS (R94-1408):
- •FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34
- •FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89
- •Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .
- •Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.
- •Adjustment for haemoglobin (R06-2002):
- •DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])
- •DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1
- •PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
排除标准
- •AST, ALT > 1.5 x ULN ;
- •Bilirubin > 1.5 x ULN
- •Relevant airways obstruction
- •Continuous oxygen supplementation at randomisation (defined as > 15 hours supplemental oxygen per day).
- •Active infection at screening or randomisation.
- •Neutrophils < 1500 / mm3
- •International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN ;
- •Platelets < 100 000 /mL
- •Haemoglobin < 9.0 g/dL
- •In the opinion of the Investigator, patient is likely to have lung transplantation during study
- •Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
- •Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
- •Myocardial infarction during the previous 6 months
- •Unstable angina during the previous month
- •Other investigational therapy received within 8 weeks prior to screening visit.
- •Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment.
- •Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
- •Known or suspected active alcohol or drug abuse.
- •Bleeding risk : Known inherited predisposition to bleeding, patients who require full-dose anticoagulation, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
- •Thrombotic risk
- •Surgical procedures planned to occur during trial period.
- •Coagulopathy
- •Uncontrolled systemic arterial hypertension
- •known hypersensitivity to lactose or any component of the study medication
研究组 & 干预措施
dose 1
Experimental
low dose BIBF1120 once daily
干预措施: low dose BIBF1120 once daily (Drug)
dose 2
Experimental
low dose BIBF 1120 twice daily
干预措施: low dose BIBF 1120 twice daily (Drug)
dose 3
Experimental
intermediate dose BIBF 1120 twice daily
干预措施: intermediate dose BIBF 1120 twice daily (Drug)
dose 4
Experimental
high dose BIBF 1120 twice daily
干预措施: high dose BIBF 1120 twice daily (Drug)
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Rate of Decline in FVC
时间窗: Baseline until 52 weeks
Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment. The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.
次要结局
- Number of Participants With Change From Baseline in FVC by Categories(Baseline and 52 weeks)
- Absolute Change From Baseline in PaCO2(Baseline and 52 weeks)
- Absolute Change From Baseline in P(A-a) O2 by Categories(Baseline and 52 weeks)
- Relative Change From Baseline in FVC%Pred(Baseline and 52 weeks)
- Absolute Change From Baseline in FVC%Pred(Baseline and 52 weeks)
- Absolute Change From Baseline in SpO2 at Rest by Categories(Baseline and 52 weeks)
- Absolute Change From Baseline in FEV1/FVC(Baseline and 52 weeks)
- Change From Baseline in SGRQ Domain Score Symptoms(Baseline and 52 weeks)
- St George's Respiratory Questionnaire (SGRQ) Responder(52 weeks)
- Change From Baseline in TLC(Baseline and 52 weeks)
- Change From Baseline in TGV(Baseline and 52 weeks)
- Absolute Change From Baseline in SpO2 at Rest(Baseline and 52 weeks)
- Absolute Change From Baseline in Distance Walk (6-MWT)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Total Score(Baseline and 52 weeks)
- Occurrences of IPF Exacerbations Per Patient Per Year(52 weeks)
- Absolute Change From Baseline in FVC(Baseline and 52 weeks)
- Relative Change From Baseline in FVC(Baseline and 52 weeks)
- Survival (All Causes of Death and Lung-transplant Free)(52 weeks)
- Absolute Change From Baseline in PaO2(Baseline and 52 weeks)
- Absolute Change From Baseline in P(A-a)O2(Baseline and 52 weeks)
- Absolute Change From Baseline in DLCO(Baseline and 52 weeks)
- Absolute Change From Baseline in PaO2 by Categories(Baseline and 52 weeks)
- Absolute Change From Baseline in DLCO by Categories(Baseline and 52 weeks)
- Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Domain Score Impacts(Baseline and 52 weeks)
- Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities(Baseline and 52 weeks)
- Change From Baseline in IC(Baseline and 52 weeks)
- Survival (Death Due to Respiratory Cause, and Lung-transplant Free)(52 weeks)
- Time to Progression(52 weeks)
- Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)(Baseline and 52 weeks)
- Absolute Change From Baseline in MRC Dyspnea Scale by Categories(Baseline and 52 weeks)
- Change From Baseline in RV(Baseline and 52 weeks)
- Number of Patients With at Least One IPF Exacerbation(52 weeks)
- Time to First Occurrence of IPF Exacerbation(52 weeks)
- Change From Baseline in VC(Baseline and 52 weeks)
- Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).(day 365 and day 729)
研究者
研究点 (92)
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