NCT00952380已完成2 期
A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 38
- 试验地点
- 26
- 主要终点
- Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
研究概览
简要总结
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
详细描述
Primary study objectives include are to determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (VTE), using anti-Xa (Xa) levels and a population PD analysis methodology, and to determine the median dose required to achieve therapeutic anti- Xa levels (0.5 to 1.0 International Units [IU]/mL) based on subject age and weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Other
Single arm open-label
干预措施: dalteparin (Drug)
结局指标
主要结局
Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
时间窗: 4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.
次要结局
- Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Absolute Values of Height of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels(4 hours post-dose at each Day 1 to 7 in dose adjustment phase)
- Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels(Day 1 to 7 in dose adjustment phase)
- Absolute Values of Weight of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase(Day 30, Day 60, Day 90 in follow-up phase)
- Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels(4 hours post-dose at each Day 1 to 7 in dose adjustment phase)
- Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Number of Participants With Laboratory Abnormalities(Baseline up to 104 days)
- Absolute Values of Body Length of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Percentage of Participants With Major and Minor Bleeding Event(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Absolute Values of Body Temperature of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Absolute Values of Respiratory Rate of Participants(Baseline, Day 1, Day 2, Day 30, Day 60, Day 90)
- Number of Participants With Physical Examination Abnormalities of Participants(Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90))
- Time to First Occurrence of Major Bleeding Event(Baseline up to 28 days after the last dose of study drug (up to Day 132))
- Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels(Day 1 to 7 in dose adjustment phase)
- Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase(Day 30, Day 60, Day 90 in follow up phase)
研究者
研究点 (26)
Loading locations...
相似试验
招募中
2 期
TiNT: Trametinib in Neurofibromatosis type 1 associated tumoursPlexiform neurofibromatosisOptic pathway gliomaCancer - Children's - BrainCancer - Children's - OtherHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersNeurological - Other neurological disordersNeurofibromatosis type 1ACTRN12620001229965Australian and New Zealand Children's Haematology/Oncology Group120
已完成
4 期
Vtama in Psoriasis Patients Being Treated With Biologics.PsoriasisNCT06103695Psoriasis Treatment Center of Central New Jersey30
已完成
3 期
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related ComplicationsInfluenzaNCT01998477Novartis Vaccines430
终止
1 期
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)Juvenile Idiopathic ArthritisNCT06222034Alfasigma S.p.A.9
已完成
3 期
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib AloneHepatocellular Carcinoma (HCC)NCT02562755SillaJen, Inc.459