NCT05629338已完成1 期
Evaluation for the Safety of FrontlineODP™ in a Multidose Randomized Cohort Study Compared With PF24
Velico Medical6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).
详细描述
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Volunteers will have their plasma collected, spray dried, and then rehydrated for infusion. Volunteers will be infused with their own (autologous) rehydrated plasma. Cohort 1 will receive 1 FrontlineODP unit that is rehydrated to approximately 200 mL. Cohort 2 will receive 2 FrontlineODP units of approximately 400 mL. Cohort 3 volunteers will receive 2 separate infusions of 4 units of approximately 800 mL of either FrontlineODP (experimental) or frozen plasma (PF24). Order of receipt of plasma product will be randomized with 14 days between infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
For Cohorts 1 and 2, blinding is not necessary because subjects will only receive a single infusion of FrontlineODP. Cohort 3 subjects will be randomly assigned to a treatment sequence and will remain blinded to the study product they receive at each visit. Study participants, the Principal Investigators, the Independent Medical Monitor, and the Data Monitoring Committee will be blinded to the randomization treatment assignments throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and nonpregnant/nonbreastfeeding females
- •For females, a minimum weight of 140 pounds and maximum weight of 220 pounds; for males, a minimum weight of 140 pounds and a maximum weight of 250 pounds
- •Subject is 18 to 65 years of age, inclusive
- •Subject self-reports that he or she feels well and healthy
- •Subject scores ≥35 on the Duke Activity Status Index
- •Subject is able to donate a unit of plasma by plasmapheresis based on the AABB Donor History Questionnaire with modifications indicated: subjects with history of travel, which puts them at risk for Creutzfeldt-Jakob Disease or malaria, are eligible to participate
- •Subject has completed a vaccination course for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with the final vaccine injection administered at least 2 weeks before enrollment
- •Subject has read the educational materials on donating blood and has had his or her questions answered
- •Subject is able and willing to provide written informed consent
- •Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation) or should use a highly effective medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a low failure rate (ie, less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, condoms with spermicide, or vasectomized partner
- •All females must have a negative urine or serum pregnancy test
- •Subject understands the English language
排除标准
- •Subject has known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune, or pulmonary disease, or treated or untreated hypertension
- •Subject has cancer of any kind, under treatment or resolved
- •Subject has known or past coagulopathy conditions
- •Subject has any conditions, uses medications, etc. on the AABB medical deferral list
- •Subject has a history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks)
- •Subject has a previous diagnosis of stroke, deep vein thrombosis (DVT), venous or arterial thrombosis, blood clots, or transient ischemic attack
- •Subject has a family history of venous or arterial thrombosis before the age of 50 years in first degree relatives (ie, biological parents, full siblings, or children)
- •Subject has a D-dimer test result ≥0.5 FEU/mL
- •Subject has a recent (within 1 year of Screening) history of an abnormal electrocardiogram of clinical significance as determined by the site PI
- •Subject has known HIV or AIDS-related illness or received a positive test result for HIV infection
- •Subject has a positive test result for HBV, hepatitis C virus (HCV), or human T-cell lymphotropic virus
- •Subject has a history of significant treated or untreated mental health issues
- •Subject is currently taking an antibiotic or another medication for an infection
- •Subject has received aspirin or other platelet-inhibiting agents within 14 days of study donation and infusion visits. Prior and concomitant medication information will be recorded beginning 30 days before enrollment through the final follow-up visit
- •Subject is currently using any medications for anticoagulant therapy
- •Subject has used clotting factor concentrates(s) (eg, FVIIa)
- •Subject has received blood or blood products within the past 12 months
- •Subject has had concurrent headache and fever in the past week
- •Subject has systolic blood pressure (current) greater than 140 mm Hg
- •Subject has diastolic blood pressure (current) greater than 90 mm Hg
- •Subject has an oral temperature greater than 100°F
- •Subject has known hematocrit ≤39% for male donors and ≤38% for female donors
- •Subject has a positive DAT result
- •Subject has received any investigational agent within 1 month before treatment infusion for this study
- •Subject is participating in any phase of any other investigational studies while participating in this study
- •Subject is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits as scheduled
- •Subject has other unspecified reasons that, in the opinion of the site PI, make the subject unsuitable for enrollment
- •Subject is institutionalized because of legal or regulatory order
- •Subject has a positive urine drug screen
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Start of first plasma infusion through 28 day follow up of the second infusion (Day 43).
Conclusions about safety will be based on the occurrence of TEAEs in Cohort 3 with infusions of 4 units (800 mL) of FrontlineODP compared to 4 units (800 mL) of PF24.
次要结局
- Changes in PT(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in aPTT(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor II(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in von Willebrand Ristocetin Cofactor (vWF:RCo) activity(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor I(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor VII(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in INR(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor XI(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in protein C(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor V(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor VIII(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor X(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in protein S(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in Factor IX(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in D-dimer(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
- Changes in von Willebrand (vWF) antigen(Start of first plasma infusion through 28-day follow up of second infusion (Day 43).)
研究者
研究点 (6)
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