EUCTR2014-004782-24-NL进行中（未招募）不适用
A Pilot Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF).
试验速览
- 阶段
- 不适用
- 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.Subject is aged 40-80 years.
- •2.Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria(Raghu, Collard et al. 2011). In the absence of a surgical lung biopsy, HRCT must be consistent with UIP” defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:
- •A.Definite honeycomb lung destruction with basal and peripheral predominance.
- •B.Presence of reticular abnormality AND traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance.
- •C.Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
- •3.If on pirfenidone, subject must have been on a stable dose of pirfenidone for at least 3 months without increase in FVC% predicted on two consecutive PFTs, including screening PFTs.
- •4.If not currently receiving pirfenidone, subject must have been off pirfenidone for = 4 weeks before baseline.
- •5.Subject has a FVC =50% and= 90% of predicted.
- •6.Subject has a DLCO =25% and = 90% of predicted.
- •7.Minimum distance on 6MWT of 150 meters.
- •8.Subject has a forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 post-bronchodilator.
- •9.Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if =55 years or 12 months if >55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
- •10.Subject has a life expectancy of at least 9 months
- •11.Subject, according to the investigator’s best judgment, can comply with the requirements of the protocol.
- •12.Subject has provided written informed consent to participate in the study.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Subject has emphysema =50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
- •2.Subject has a history of cigarette smoking within the previous 3 months.
- •3.Subject has received investigational therapy for IPF within 4 weeks before baseline.
- •4.Subject has received nintedanib within the 4 weeks before baseline.
- •5.Subject is receiving systemic corticosteroids equivalent to prednisone> 10 mg/day or equivalent within 2 weeks of baseline.
- •6.Subject received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
- •7.Subject has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
- •8.Subject has any concurrent condition other than IPF that, in the Investigator’s opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject’s ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
- •9.Subject has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
- •10.Subjects that are unable to refrain from use of the following:
- •a)Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
- •b)Long acting bronchodilators on the day of and within 24 hours of these assessments.
- •11.Subject has a known post bronchodilator (short acting beta agonist [SABA] – albuterol or salbutamol) increase in FEV1of >10% and in FVC of >7.5%.
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