EUCTR2010-022514-47-FR进行中（未招募）1 期
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tabletsin Pediatric Kidney Transplant Recipients - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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. Parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study.
- •2. Patient has received a kidney transplant.
- •3. Males or females aged between 4 months and = 16 years.
- •4. Patient at risk of developing CMV disease (including R+ who are at
- •risk of CMV due to other factors determined by the treating
- •physician).
- •5. Patient has adequate hematological and renal function defined as:
- •Absolute neutrophil count (ANC) >1300 cells/µL
- •Platelet count >40,000 cells/µL
- •Hemoglobin >8.0 g/dL
- •Estimated Schwartz creatinine clearance (>15 mL/min) to allow for dosing according to algorithm
- •6. Patient is able to tolerate oral medication (any standard practice tube
- •feeding is acceptable).
- •7. Negative pregnancy test (blood or urine) for females of child bearing
- •potential before initiation of valganciclovir treatment.
- •8. Patients of reproductive potential agree to utilize an effective method
- •of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has exhibited an allergic or other significant adverse reaction
- •to acyclovir, valacyclovir or ganciclovir in the past.
- •2. Patient has severe, uncontrolled diarrhea (more than 5 watery stools
- •3. Patient has liver enzyme elevation of more than five times the upper
- •limit of normal for AST (SGOT) or ALT (SGPT).
- •4. Patient requires use of any protocol prohibited concomitant
- •medications.
- •5. Patient has previously participated in this clinical study.
- •6. Patient is a lactating female who will not discontinue nursing prior to
- •study entry.
- •7. Patient is simultaneously participating in another clinical study except as approved by the Sponsor.
研究者
相似试验
进行中（未招募）
不适用
Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney TransplantTreatment and prevention of CMV disease in kidney transplant recipientsMedDRA version: 16.0Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 100000004862MedDRA version: 16.0Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862MedDRA version: 16.0Level: LLTClassification code 10009701Term: CMVSystem Organ Class: 100000004848MedDRA version: 16.0Level: LLTClassification code 10060577Term: CMV viremiaSystem Organ Class: 100000004862EUCTR2010-022514-47-SEF. Hoffmann-La Roche Ltd.50
进行中（未招募）
1 期
Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney TransplantEUCTR2010-022514-47-GBF. Hoffmann-La Roche Ltd.57
进行中（未招募）
1 期
Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney TransplantTreatment and prevention of CMV disease in kidney transplant recipientsMedDRA version: 14.0Level: LLTClassification code 10009701Term: CMVSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: LLTClassification code 10060577Term: CMV viremiaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-022514-47-ESF. Hoffmann-La Roche Ltd.57
进行中（未招募）
不适用
Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney TransplantTreatment and prevention of CMV disease in kidney transplant recipientsMedDRA version: 14.1Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 100000004862MedDRA version: 14.1Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862MedDRA version: 15.1Level: LLTClassification code 10009701Term: CMVSystem Organ Class: 100000004848MedDRA version: 14.1Level: LLTClassification code 10060577Term: CMV viremiaSystem Organ Class: 100000004862EUCTR2010-022514-47-DEF. Hoffmann-La Roche Ltd.50
已完成
4 期
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant RecipientsKidney Transplantation, Cytomegalovirus InfectionsNCT01376804Hoffmann-La Roche57