CTRI/2020/09/027897招募中2 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
- •2) A diagnosis of IPF within 3 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines
- •3) Age ââ?°Â¥40 years
- •4) FVC ââ?°Â¥60% 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) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c:
- •a. A pattern consistent with usual interstitial pneumonitis (UIP) according to either
- •ATS/ERS/JRS/ALAT or Fleischner guidelines (
- •ii.Probable UIP
- •b. A pattern indeterminate for UIP according to either ATS/ERS/JRS/ALAT or Fleischner guidelines (and a historical biopsy consistent with IPF
- •c. Extent of fibrosis > extent of emphysema
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 1Acute worsening or development of dyspnoea typically <1 month duration
- •Ã¢â?¬Â¢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 ââ?¬Å?newââ?¬? can be dropped)
- •Ã¢â?¬Â¢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:
- •Ã¢â?¬Â¢Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnââ?¬•s Wort)
- •Ã¢â?¬Â¢CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
- •Ã¢â?¬Â¢Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
- •Ã¢â?¬Â¢Experimental drugs
- •Ã¢â?¬Â¢Any systemic immunosuppressive therapies other than:
- •o Inhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable
- •o Corticosteroids for the treatment of acute exacerbations
- •o The 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:
- •Ã¢â?¬Â¢Proton pump inhibitors (PPIs) more than once daily
- •Ã¢â?¬Â¢Histamine H2 receptor antagonists (H2RAs)
- •Ã¢â?¬Â¢Breast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin)
- •9) Any of the following findings at Visit 1:
- •Ã¢â?¬Â¢Prolonged QTcF (QT interval with Fridericiaââ?¬•s correction) ( >450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the investigator
- •Ã¢â?¬Â¢Positive 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
- •Ã¢â?¬Â¢Positive 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 , 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
- •13) Female 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 <br/
研究者
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