임상 레이더 AI | ||
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임상시험 NCT06958796 (SHIELD)은(는) 거대세포바이러스, 장기 이식, 신장 이식; 합병증, 간 이식; 합병증, Simultaneous Liver-Kidney Transplantation; Complications에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) (SHIELD) 4상 80 예방적
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06958796 (SHIELD)은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 거대세포바이러스, 장기 이식, 신장 이식; 합병증, 간 이식; 합병증, Simultaneous Liver-Kidney Transplantation; Complications에 대해 진행되며, 4상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 11월 27일에 시작되어 80명의 참여자를 모집하고 있습니다. Camille N. Kotton, MD이(가) 진행하며, 2028년 5월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 22일에 갱신되었습니다.
간단한 개요
This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.
상세한 설명
This research study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help people with a high risk for developing late CMV disease post-transplant.
Cytomegalovirus (CMV) is a very common virus and in the same family as the viruses that cause herpes, chickenpox, and mononucleosis. Most people become infected with the virus when they come in d...
더 보기공식 제목
Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection
질환명
거대세포바이러스장기 이식신장 이식; 합병증간 이식; 합병증Simultaneous Liver-Kidney Transplantation; Complications출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- SHIELD
- 2024P003592
NCT 번호
실제 연구 시작일
2025-11-27
최신 업데이트 게시
2025-12-22
예상 연구 완료일
2028-05-31
계획된 등록 인원
80
연구종류
중재연구
단계/상
4상
상태
모집중
키워드
cytomegalovirus
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Arm A: CytoGam® Participants assigned to receive CytoGam® will receive an infusion once a month for three months at their study site. The infusion will be completed over an average of about 4 hours; these three visits will last about 5 hours. During these study staff will review concomitant medications and adverse events. Participants will be asked to have blood taken at infusion visits and 2 weeks after an infusion visit to check t...더 보기 | Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months The interventional arm will receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months as (150 mg/kg) for 3 consecutive months (Days 0, 28 and 56 +/- 3 days). The non-interventional arm will not receive any intervention. |
비개입Arm B: Standard of Care Participants assigned to Arm B, will be asked to complete a telephone call visit once a month. During these visits, a member of study staff will review concomitant medications and adverse events. Participants will be asked to have their blood taken every two weeks to check the level of CMV DNA. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants with Late Clinically Significant CMV Disease | Comparison between treatment groups of number of participants with a blood CMV viral load \>1000 IU/ml at any point during the treatment phase through end of study | Treatment Phase (Day 0) through End of Study (Day 168) |
Number of Participants with Adverse Events Related to CMV | Congregate data of all Adverse Events (including Serious Adverse Events) will be compared between treatment arms. The number and percent of CMV related AEs will be summarized by:
Organ system impacted Relationship to CMV Severity Deaths
Those leading to:
1. Initiation of CMV treatment
2. Hospitalization due to CMV | Events starting after or increasing in severity following initiation of the Treatment Phase (Day 0) through end of study (Day 168) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Peak CMV DNA Levels | Comparison of peak CMV DNA levels (DNAemia/viremia) between treatment groups using either the Wilcoxon rank-sum test or Student's t-test, depending on the distribution of the data; DNA tests will be completed every 2 weeks throughout the trial and reported in IU/ml | From Enrollment, through the Treatment Phase (Day 0) until the end of study (Day 168) |
Change in CMV DNA Levels Across Study Groups | Trend the change and differences in CMV viral loads over time between groups using a mixed-effects model with biweekly CMV DNA test results | From Enrollment, through the Treatment Phase (Day 0) until the end of study (Day 168) |
Time to First Detectable CMV DNAemia | Time to onset of CMV DNAemia/viremia summarized by treatment group measured by week of onset after day 0 (end of valganciclovir prophylaxis) | Treatment Phase (Day 0) through End of Study (Day 168) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients
- Able to do routine blood testing (normal care for transplant recipients)
- Written informed consent obtained from the subject before any trial-related procedures
- Be ≥18 years and ≤75 years of age at time of consent
- Any pre-transplant CMV serologic combinations besides CMV D+/R-
- Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant
- Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients
- Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis
- Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent
- Transplant recipients with eGFR <30 ml/min/1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs > twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.
- Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations
- Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)
- Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening
- History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \[e.g., severe pulmonary hypertension (WHO class IV)\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions
- Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)
- Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
- Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or "tubes tied"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.
- Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Subjects who have any of the following laboratory values: eGFR <30 ml/min/1.73m2 ; Hemoglobin <8.0 g/dL; Platelets <50,000 cells/uL; Absolute neutrophil count <1,000 cells/uL; Total bilirubin >2.5 x upper limit of normal; Alanine aminotransferase (ALT) >5 x upper limit of normal; Aspartate aminotransferase (AST)] >5 x upper limit of normal; CMV IgG negative in donor or positive in recipient
Camille N. Kotton, MD- 텍사스 대학교 사우스웨스턴 메디컬 센터
연구 책임자
Camille N. Kotton, MD, 의뢰자-연구자, Camille N. Kotton, MD, Clinical Director of Transplant Infectious Disease, Massachusetts General Hospital
연구 대표 연락처
연락처: Amelia Stocking, BS, 617-643-4087, [email protected]
연락처: Camille Kotton, MD, 6177240084, [email protected]
2 1개국에 임상시험 장소
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
MGH Abdominal Transplant Unit, 연락처, 617-643-4087, [email protected]
Camille Kotton, MD, 책임연구자
모집중
Texas
University of Texas Southwestern, Dallas, Texas, 75390, United States
Jarrett Hubbard, BA, 연락처, 214-648-3111, [email protected]
David Wojciechowski, DO, 연락처, (214) 648-3111, [email protected]
David Wojciechowski, DO, 책임연구자
모집중