EUCTR2014-004782-24-CZ进行中（未招募）1 期
A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
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
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 or nintedanib, subject must have been on a stable dose of pirfenidone or nintedanib for at least 3 months without increase in FVC% predicted on two consecutive PFTs, including screening PFTs. Subjects may not be on both pirfenidone and nintedanib.
- •4.If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib 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.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
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 is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline.
- •5.Subject received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
- •6.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.
- •7.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.
- •8.Subject has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
- •9.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.
- •10.Subject has a known post bronchodilator (short acting beta agonist [SABA] – albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
研究者
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