EUCTR2020-005072-34-GR进行中（未招募）1 期
A Phase 2a, double-blind, randomised, placebo controlled, efficacy, and safety study of multiple doses of VIT-2763 in subjects with sickle cell disease (ViSion Serenity) - VIT-2763-SCD-202
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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 has provided the appropriate written informed consent before any study-specific procedures are performed including screening procedures.
- •2. Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.
- •3. Male or female subjects with confirmed diagnosis of SCD, including only HbS/S or HbS/ßT0 genotype.
- •4. Subjects who had at least 1 and no more than 10 VOC episodes reported within 12 months prior to screening. Note: A VOC episode is defined as a documented episode of acute chest syndrome or acute painful crisis for the main
- •indication of SCD, which led to health-professional instructed prescription or use of opioids (excluding codeine) for moderate to severe pain.
- •5. 18 to 60 years of age inclusive at the time of screening.
- •6. Body weight =40 kg and =120 kg at screening and baseline.
- •7. Absolute reticulocyte count or and percentage reticulocyte count >1.5 × ULN during screening.
- •8. Subjects on concomitant hydroxyurea must be on a stable dose (mg/kg) for =3 months prior to screening Visit V1.
- •There should be no planned dose adjustments during the course of the study in the opinion of the Investigator.
- •9. Female subjects of childbearing potential, must have negative pregnancy tests at screening (serum pregnancy test) and before randomisation (urine pregnancy test), must have stopped breastfeeding as of first dose, and must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or must be willing to use adequate contraceptive precautions, i.e., highly effective method of birth control. Abstinence should only be used as a contraceptive method if it is in line with the subject´s usual and preferred lifestyle, and periodic abstinence (calendar symptothermal, postovulation methods) is not acceptable method of contraception. Female subjects must agree to use adequate contraception during the study and until at least 1 week after the last dose of IMP or requirements from other co-medications taken, e.g. hydroxyurea or according to local
- •requirements, whichever is longer. Effective contraception (highly effective method of birth control, i.e., with a failure rate of <1% per year, when used consistently and correctly) such as implants, injectables, combined oral
- •contraceptives (see below), intrauterine devices, sexual abstinence, or vasectomised partner must be used. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study.
- •Note: For female subjects participating in this study, continuous use of hormonal contraception alone is not sufficient, because potential interactions via CYP enzymes may alter the efficacy of hormonal contraception. The continuous use
- •of hormonal contraception by a female subject should be combined with the use of a condom by the male partner; the condom should then be used together with a spermicide or adequate and approved alternatives by the (fertile) male partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Subjects with confirmed SCD diagnosis other than HbS/S and HbS/ßT0.
- •2. Hb level <6.0 g/dl or >10.4 g/dl for female and >11.0 g/dl for male subjects at screening Visit V1.
- •Note: The Hb value at screening Visit V1 will be used for eligibility determination based on the central laboratory result. However, the baseline Hb value determined at Visit V2 (Day 1 pre-dose) also needs to be within the above specified range, based on the local laboratory result.
- •3. Having received RBC transfusion therapy within 4 weeks prior to screening, or ongoing or planned RBC transfusion therapy during the course of the study (including chronic, prophylactic, or preventive transfusion to treat SCD).
- •4. Subject with serum ferritin level <30 µg/l at screening.
- •5.Calculated TSAT level <25% at screening. However, in case TIBC is within normal ranges of the central laboratory values, the subject will not be excluded.
- •6. Subjects being hospitalized for SCD-related events (including pain crisis and VOC) within 14 days before the screening visit.
- •Note: SCD must have been the main cause for the hospitalisation to fulfil this criterion.
- •7. Chronic liver disease or history of liver cirrhosis, and/or alanine aminotransferase or aspartate aminotransferase,
- •above 3-fold the ULN range at baseline.
- •8. eGFR <45 ml/min/1.73 m2,at screening or on chronic dialysis. Note: eGFR should be estimated according to CKD-EPI formula.
- •9. Newly diagnosed folate deficiency anaemia (i.e., folic acid <2 ng/ml), which is considered clinically relevant by the Investigator at screening. Subjects with known folate deficiency anaemia who are on =12 weeks stable replacement therapy at screening are eligible.
- •10. Subjects with history of partial or total splenectomy within 3 months prior to the screening visit.
- •11. Any history or clinically important finding of cardiac or pulmonary disorders, including (but not limited to) clinically relevant or uncontrolled cardiac arrhythmia, cardiomyopathy, coronary disease (unstable angina pectoris or myocardial
- •infarction or elective coronary intervention), valve disorder, or heart failure according to New York Heart Association classification 3-4.
- •12. A diagnosis of any form of pulmonary hypertension.
- •13. Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomisation (as deemed by the Investigator) including (but not limited to) any of the following:
- •- PR interval >0.21 seconds
- •- Evidence or history of second- or third-degree atrioventricular block
- •- QRS interval >0.12 seconds
- •14. Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer) or subjects with QT interval corrected (QTcF) >450 msec.
- •15. Clinically significant bacterial, fungal, parasitic, or viral infection which requires therapy. Note: Please see the protocol
- •16. Known history, and/or positive result on screening for hepatitis B surface antigen,
- •hepatitis B virus, hepatitis C virus, or HIV infection. Note: Please see the protocol
- •17.Known active COVID-19 infection (positive result of a SARS-Cov-2 virus test (nucleic acid or antigen detection) within 2 weeks preceding screening), or any other active infection. Note: Please see the protocol
- •18. Use of any prohibited medication(s) - see the Protocol for the details.
- •19. Concomitant use of hormonal contraceptives which are metabolised through CYP 3A4
研究者
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