EUCTR2024-000203-67-Outside-EU/EEA进行中（未招募）1 期
A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study) - ROCKstar
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •1.Male and female participants at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
- •2.Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
- •3.Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
- •4.Have persistent cGVHD manifestations and systemic therapy is indicated
- •Karnofsky Performance Score of = 60 (if aged 16 years or older); Lansky
- •5.Performance Score of = 60 (if aged < 16 years)
- •6.Weight = 40kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 23
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 221
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1.Participant has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
- •2.Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
- •3.Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization
研究者
相似试验
尚未招募
2 期
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for Head and Neck CancerOral MucositisHead and Neck CancerCancer - Head and neckOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12620000540910PSI CRO Australia Pty. Ltd.110
未知
2 期
Efficacy and Safety Study of CNTO 2476 in Participants with Visual Acuity Impairment Associated with Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)JPRN-jRCT1080223359Janssen Pharmaceutical K.K.60
进行中（未招募）
1 期
A clinical trial in patients with the liver disease caused by the hepatitis C virus for assessment of safety and efficacy of RG-101 injections (test product) given in combination with other registered drugs that are to be taken by mouthEUCTR2015-001535-21-HURegulus Therapeutics Inc.54
进行中（未招募）
1 期
A clinical trial in patients with the liver disease caused by the hepatitis C virus for assessment of safety and efficacy of RG-101 injections (test product) given in combination with other registered drugs that are to be taken by mouthTreatment Naïve, Genotype 1 and 4, Chronic Hepatitis C PatientsMedDRA version: 18.0Level: LLTClassification code 10076315Term: Hepatitis C virus genotype 4 positiveSystem Organ Class: 100000004848MedDRA version: 18.0Level: LLTClassification code 10074391Term: Chronic hepatitis C virus genotype 1System Organ Class: 100000004862EUCTR2015-001535-21-GRRegulus Therapeutics Inc.54
进行中（未招募）
不适用
A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination with Chlorambucil, and that of Chlorambucil alone, in Patients with Chronic Lymphocytic Leukemia (CLL) -Chronic Lymphocytic Leukemia (CLL)EUCTR2004-000440-24-SECephalon UK Limited80