CTIS2023-507353-15-00进行中（未招募）1 期
An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON) - 1305-0031
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption), Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial, Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information. For France, fertile males must be ready and able to use acceptable methods of birth control
排除标准
- •Any disease that may put the patient at risk when participating in this trial at investigator’s discretion., Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant)., Women who are pregnant, nursing, or who plan to become pregnant while in the trial., Previous enrolment in this trial., Participation in another interventional study., Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1: - any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) - any suicidal ideation of type 4 or 5 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent), Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore >14 at Visit 1., An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1., Patient will undergo lung transplantation, with an assigned date of surgery., Patients with a BMI <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial, At Visit 1, patients with ongoing AESI (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial, Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial., Patient not compliant in parent trial (1305-0014 or 1305-0023) with trial medication or trial visits, according to investigator’s judgement.
研究者
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