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治験 NCT06958796 (SHIELD)（対象：サイトメガロウイルス、臓器移植、腎移植; 合併症、肝移植の合併症、Simultaneous Liver-Kidney Transplantation; Complications）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) (SHIELD) 第IV相・フェーズ4 80 予防的
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06958796 (SHIELD) は サイトメガロウイルス、臓器移植、腎移植; 合併症、肝移植の合併症、Simultaneous Liver-Kidney Transplantation; Complications に関する 予防 の研究で、第IV相・フェーズ4 介入研究 臨床試験 です。現在は 募集中 で、2025年11月27日 から開始しています。80 名の参加者 の募集が計画されています。この試験は Camille N. Kotton, MD によって主導され、2028年5月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月22日 です。
概要
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.
詳細説明
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...
もっと見る公式タイトル
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
疾患名
サイトメガロウイルス臓器移植腎移植; 合併症肝移植の合併症Simultaneous Liver-Kidney Transplantation; Complications刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- SHIELD
- 2024P003592
NCT番号
開始日
2025-11-27
最終更新日
2025-12-22
終了予定日
2028-05-31
目標参加者数
80
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
募集中
キーワード
cytomegalovirus
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm 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...もっと見る | 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. |
非介入Arm 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. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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- テキサス大学南西部医学センター
責任者
Camille N. Kotton, MD, 治験依頼者・主任研究者, Camille N. Kotton, MD, Clinical Director of Transplant Infectious Disease, Massachusetts General Hospital
試験中央連絡先
連絡先: Amelia Stocking, BS, 617-643-4087, [email protected]
連絡先: Camille Kotton, MD, 6177240084, [email protected]
2 1カ国の場所
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
MGH Abdominal Transplant Unit, 連絡先, 617-643-4087, [email protected]
Camille Kotton, MD, 主任研究者
募集中
Texas
University of Texas Southwestern, Dallas, Texas, 75390, United States
Jarrett Hubbard, BA, 連絡先, 214-648-3111, [email protected]
David Wojciechowski, DO, 連絡先, (214) 648-3111, [email protected]
David Wojciechowski, DO, 主任研究者
募集中