EUCTR2019-001106-23-GB进行中（未招募）1 期
An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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. Subjects at least 18 years of age with PNH who have participated in a Pegcetacoplan (APL-2) clinical trial.
- •Subjects who received treatment with Pegcetacoplan (APL-2) must have experienced
- •clinical benefit and adequate tolerability in the opinion of the Investigator.
- •Note: Subjects with PNH who completed an Pegcetacoplan (APL-2) clinical trial without
- •receiving Pegcetacoplan (APL-2) (or without receiving Pegcetacoplan (APL-2) for long enough to
- •demonstrate clinical benefit) may be enrolled in this study if, in the
- •opinion of the Investigator, the subject is expected to demonstrate
- •clinical benefit upon the initiation or continuation of Pegcetacoplan (APL-2) therapy.
- •2. Vaccination against Neisseria meningitidis types A, C, W, Y and B, Streptococcus
- •pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day
- •1 dosing of this study, or within 14 days after starting treatment with pegcetacoplan.
- •Vaccination is mandatory unless documented evidence exists that subjects are
- •nonresponders to vaccination as evidenced by titers or display titer levels within
- •acceptable local limits. Immunization status checks will be performed to determine
- •whether subjects require primary or booster vaccinations.
- •3. Willing and able to give written informed consent.
- •4. Willing and able to self-administer pegcetacoplan (administration by a caregiver will be
- •5. Women of childbearing potential (WOCBP), defined as any females who
- •have experienced menarche and who are NOT permanently sterile or postmenopausal, must have a negative
- •pregnancy test and must agree to continue to use an approved method
- •of contraception for the duration of the study and 90 days after their last
- •dose of study drug. Note: Postmenopausal is defined as 12 consecutive months with no menses
- •without an alternative medical cause.
- •6. Males must agree to continue to use an approved method of
- •contraception and must agree to refrain from donating sperm for the
- •duration of the study and 90 days after their last dose of study drug.
- •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 129
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •1. Subjects who withdrew from a Pegcetacoplan (APL-2) clinical study clinical study and/or subjects who met study drug discontinuation criteria during a pegcetacoplan clinical study.
- •2. Any condition that could increase the subject’s risk by participating in the study
- •3. Any comorbidity or condition (such as malignancy) that, in the opinion of the
- •investigator, could put the subject at increased risk or potentially confound the study data.
- •4. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to
- •the investigational product or SC administration.
- •5. Known infection with hepatitis B, C, or HIV.
- •6. Hereditary complement deficiency.
- •7. History of bone marrow transplant.
- •8. Concurrent severe aplastic anemia (SAA), defined as currently receiving
- •immunosuppressive therapy for SAA including but not limited to cyclosporin A,
- •tacrolimus, mycophenolate mofetil, or anti-thymocyte globulin.
- •9. History of meningococcal disease.
- •10. Concomitant treatment with any complement inhibitor (eg, eculizumab, ravulizumab).
- •11. Pregnancy, breastfeeding, or positive pregnancy test.
研究者
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