PACTR202102669041711尚未招募3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle cell Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •Participants who meet all the following criteria will be eligible for enrollment in this study:
- •1.Male or female participants with documented diagnosis of SCD one sickle gene with 2 sickle cell genes [HbSS], sickle hemoglobin and one beta thalassemia gene [HbS/ß0] thalassemia
- •2.Age 12 years and older
- •3.At least 1 cutaneous ulcer on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:
- •Duration: = 2 weeks and < 6 months at Screening, and
- •Size: > 2 square centimeters (cm2) prior to randomization
- •Note: Participants with multiple ulcers are eligible for the study. For each participant, target ulcer(s) for evaluation in this study will be identified and tracked. To qualify as a target ulcer, the ulcer must meet the criteria above.
- •4.Participants, who if female and of child-bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of study drug and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of study drug.
- •5.Females of child-bearing potential are required to have a negative pregnancy test before the administration of study drug.
- •6.Written informed consent (= 18 years) or parental/guardian consent and participant assent (= 12–17 years) per International Ethics Committee (IEC) policy and requirements, consistent with International Council for Harmonisation (ICH) guidelines
排除标准
- •Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
- •1.Target ulcer(s) healed by = 25% during the SOC Run-in prior to randomization
- •Note: For participants with multiple ulcers, the participant is not eligible for the study if all target ulcers have healed by = 25% during the SOC Run-in.
- •2.Active infection/purulence at ulcer site, or exposed tendon or bone at the ulcer site, based on Investigator’s clinical judgment
- •3.Current osteomyelitis at or near the ulcer site
- •4.Known vascular abnormalities that would preclude healing in the opinion of the Investigator (eg, pre-existing severe arterial insufficiency in the affected limb)
- •5.Serum albumin < 2.0 g/dL
- •6.Red blood cell (RBC) transfusion within 60 days of initiation of study drug
- •7.Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) during the study
- •8.Planned elective surgery within the next 6 months
- •9.Anemia due to bone marrow failure (eg, myelodysplasia)
- •10.Absolute reticulocyte count < 100 × 109/L
- •11.Screening alanine aminotransferase (ALT) > 4 × upper limit of normal (ULN)
- •12.Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 by Schwartz formula) or is on chronic dialysis
- •13.Clinically significant bacterial, fungal, parasitic, or viral infection that requires therapy:
- •Participants with acute bacterial infection requiring systemic antibiotic use should delay Screening/enrollment until the course of antibiotic therapy has been completed
- •Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive
- •Participants with active SARS-CoV-2 infection (COVID-19)
- •14.Females who are breast-feeding or pregnant
- •15.History of hematopoietic stem cell transplant or gene therapy
- •16.Participated in another clinical trial of an investigational product (or medical device) within 30 days or 5 half-live
研究者
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