EUCTR2020-000822-24-GB进行中（未招募）1 期
A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis - C21 in IPF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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) Written informed consent obtained before the initiation of any trial related procedure
- •2) A diagnosis of IPF within 3 years prior to Visit 1
- •3) Age =40 years
- •4) FVC =80% predicted at Visit 1
- •5) FEV1/FVC ratio >0.7 prebronchodilator at Visit 1
- •6) Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
- •7) Diffuse capacity for carbon monoxide (DLCO) >30% of predicted normal corrected for haemoglobin at Visit 1
- •8) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating:
- •a. A pattern consistent with usual interstitial pneumonitis (UIP)
- •b. Extent of fibrosis > extent of emphysema
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1)Previous and concomitant use of nintedanib or pirfenidone
- •2)Smoking (including e-cigarettes) within 6 months prior to Visit 1
- •3)Body mass index (BMI) >35 or <18
- •4)IPF exacerbation within 3 months prior to Visit 1, as defined by Collard et al. (2016):
- •Acute worsening or development of dyspnoea typically <1 month duration
- •Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier new” can be dropped)
- •Deterioration not fully explained by cardiac failure or fluid overload
- •5)Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery) which in the opinion of the investigator makes the subject inappropriate for this trial
- •6)Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
- •7)Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
- •Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John’s Wort)
- •CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
- •Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
- •Experimental drugs
- •Any systemic immunosuppressive therapies other than:
- •oInhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable
- •oCorticosteroids for the treatment of acute exacerbations
- •oThe continuation of stable doses of <15 mg daily doses of prednisolone
- •8)Treatment with any of the medications listed below within 2 weeks prior to Visit 1:
- •oProton pump inhibitors (PPI’s) more than once daily
- •oHistamine H2 receptor antagonists (H2RA’s)
- •oBreast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin)
- •9)Any of the following findings at Visit 1:
- •oProlonged QTcF (QT interval with Fridericia’s correction) (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
- •oPositive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
- •oPositive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
- •10)Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline (Miller et al. 2005), as determined by central review
- •11)Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator
- •12)Pregnant or breast-feeding female subjects
- •13Female subjects of childbearing potential not willing to use contraceptive methods
- •14)Male subjects not willing to use contraceptive methods
- •15)Subjects not willing to adhere to dietary restrictions during the trial period
- •16)Participation in any other interventional trial during the trial period
- •17)Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
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