CTIS2023-505766-28-00招募中1 期
A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) - PHA022121-C303
Pharvaris Netherlands B.V.0 个研究点目标入组 20 人开始时间: 2023年10月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- •1. Provision of written informed consent., 2. Male or female, aged = 18 years at the time of providing written informed consent., 3. Patients must have received at least 1 dose of study drug (including the non-attack visit) in Study PHA022121-C201., 4. Female patients of childbearing potential must agree to the protocol specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable form of contraception methods from enrollment until 30 days after the last study drug administration. Methods acceptable for this study include male condom with or without spermicide, cervical cap, diaphragm or sponge with spermicide, a combination of male condom with cap, diaphragm or sponge with spermicide (double-barrier methods), progestin-only hormonal methods (oral, injectable, or implantable), intrauterine device (IUD, all types), intrauterine hormone releasing systems (IUS). Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal (defined as no menses for at least 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) test result indicative of post-menopausal status) do not require contraception during the study. There are no contraceptive requirements for male patients., 5. In the opinion of the investigator is willing and able to comply with the protocol.
排除标准
- •1. Any female who is pregnant or is breast-feeding., 2. Presence of any medical condition that could interfere with the assessment of safety or efficacy or negatively affect the patient’s safety, including clinically significant abnormal ECG, most notably a QTcF > 470 ms (for females) or > 450 ms (for males), cardiovascular disease, abnormal liver function and abnormal kidney function., 3. Any other systemic disease (e.g., gastrointestinal, renal, respiratory, neurological) or significant disease or disorder that would interfere with the patient’s safety or ability to participate in the study., 4. Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior to study enrollment., 5. Patients who have recently used short or long-term HAE prophylaxis or on-demand HAE treatment will not be excluded from the study provided the following washout period is observed (i.e., study screening or enrollment should be delayed allowing for washout): • 2-week washout period before enrollment should be respected for patients who have used any C1-INH product, oral kallikrein inhibitors, attenuated androgens, or anti-fibrinolytics for long-term prophylactic HAE therapy. • 1-week washout period before enrollment should be respected for patients who have used plasma derived C1-INH concentrates (Berinert, Cinryze, Haegarda) for on-demand treatment or short-term prophylaxis. • 24-hour washout period before enrollment should be respected for patients who have used recombinant C1-INH (Ruconest) for on-demand treatment or short-term prophylaxis., 6. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse, 7. Discontinued from Study PHA022121-C201 after enrollment for any study drug-related safety reason., 8. Participation in any other investigational drug study (except with PHA-022121) currently, within the last 30 days prior to the first PHA-022121 dose or within 5 half-lives of study drug at enrollment, whichever is longer., 9. Use of concomitant medications that are potent CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) or potent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort).
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