EUCTR2007-004729-16-GB进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTS
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 348
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
- •Subjects must:
- •1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- •2. Be = 18 years of age.
- •3. Weigh = 40 kg.
- •4. Be undergoing their first orthotopic liver transplantation (the transplanted graft may be a deceased-donor whole organ, a deceased-donor split-liver graft, or live-donor graft).
- •5. Have negative pre-transplantation CMV serology and receive a liver from a donor
- •with positive pre-transplantation CMV serology (i.e., donor positive / recipient
- •negative [D+ R–]).
- •6. Have no detectable CMV infection post-transplant. This must be documented by
- •CMV testing of blood using either CMV pp65 antigenemia assay, CMV DNA PCR,
- •or other CMV DNA detection assay from a sample collected post-transplant. Results
- •from either the central laboratory or a local laboratory can be used for qualification.
- •7. Have the following findings as part of screening laboratory assessments (results
- •from either the central laboratory or a local laboratory can be used for
- •qualification):
- •Absolute neutrophil count (ANC) =500/mm3 [0.5 x 109/L]
- •Platelet count =25,000/mm3 [25 x 109/L]
- •8. Be randomized such that dosing with study drug can begin within 10 days posttransplant.
- •9. If female, be either postmenopausal, surgically sterile, or have a negative serum
- •pregnancy test as part of screening laboratory assessments. Women of child bearing
- •potential also must agree to use an acceptable method of birth control (e.g.,
- •abstinence, IUD, or barrier method), as determined by the investigator, during the
- •study drug administration period and for 3 months afterward. Hormonal
- •contraceptives should not be used as the sole method of birth control.
- •If male, must agree to use an acceptable method of birth control (e.g., abstinence or
- •barrier method), as determined by the investigator, during the study drug
- •administration period and for 3 months afterward.
- •10. Be able to swallow tablets and capsules.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must not:
- •1. Be undergoing multi-organ transplantation or have undergone prior organ
- •transplantation (except skin, hair, or cornea).
- •2. Have known human immunodeficiency virus (HIV) infection (based on testing
- •performed during the transplant evaluation process or during screening for this study).
- •3. Have CMV-related organ disease within 6 months prior to the day of enrollment.
- •4. Be receiving any of the following therapies at the time of enrollment:
- •ganciclovir
- •valganciclovir
- •foscarnet
- •cidofovir
- •acyclovir (>25 mg/kg IV per day)
- •valacyclovir (>3 g p.o. per day)
- •famciclovir (>1500 mg p.o. per day)
- •NOTE: A subject may have received any of the above listed drugs prior to
- •enrollment. If this is the case, these drugs must be discontinued by the time of
- •enrollment; no minimum washout” period is required before commencement of
- •dosing with study drugs.
- •5. Have received cytomegalovirus immune globulin within 30 days prior to the day
- •of enrollment.
- •6. Have estimated creatinine clearance <10 mL/min or require dialysis at time of
- •enrollment.
- •7. Have severe vomiting, diarrhea or other severe gastrointestinal illness within
- •24 hours prior to the time of enrollment that would preclude administration of oral
- •medication.
- •8. Require mechanical ventilation or vasopressors for hemodynamic support at time
- •of enrollment.
- •9. Be pregnant (as determined by ß-hCG testing prior to initiation of study drug) or
- •breastfeeding.
- •10. Have received any investigational antiviral agent or investigational
- •immunosuppressant agent within 30 days before the initiation of study drug.
- •11. Have received maribavir in a previous clinical trial.
- •12. Have any clinically significant medical or surgical condition (other than the
- •underlying reason for transplantation) that in the investigator’s or sponsor’s
- •opinion would compromise the outcome of the study.
研究者
相似试验
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTSEUCTR2007-004729-16-ATViroPharma Incorporated348
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTSEUCTR2007-004729-16-DEViroPharma Incorporated348
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTSMain purpose is to assess the efficacy and safety of prophylactic use of oral Maribavir versus oral Ganciclovir to prevent cytomegalovirus disease in recipients of orthotopic liver transplants at high risk of developing CMV disease.MedDRA version: 9.1Level: LLTClassification code 10009701Term: CMVEUCTR2007-004729-16-BEViroPharma Incorporated348
已完成
不适用
DOUBLE BLIND STUDY, RANDOMIZED, TO EVALUATE THE EFFICACY AND CLINICAL SAFETY OF FOUR DOSE OF ORDERSTRAND ORAL IN ASSOCIATION WITH 10 MG. DEXECADOTRIL IN CHILD MALE FROM 3 TO 36 MONTHS AGE, WITH ACUTE DIARRHEA OF ALLEGED INFECTIOUS ORIGIPER-033-07CONSULTORES ASOCIADOS PARA EL DESARROLLO DE LA SALUD. DS-CONSULT S.A.C.,
进行中（未招募）
不适用
Selumetinib therapy in patients with Metastatic Uveal MelanomaEUCTR2013-003545-41-FIAstraZeneca AB128