NCT07013370 Immunoglobiulin-specific Prophylaxis of Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07013370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Antonello Di Paolo, M.D., Ph.D. |
| Condition | Immunoglobulin Prophylaxis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-06-02 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Human cytomegalovirus (CMV) is a globally prevalent, human-specific herpesvirus characterised by a lifelong latency after primary infection, an often asymptomatic reactivation and affecting up to 100% of adults based on region and age. CMV reactivation has serious risks for immunocompromised patients, especially those undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In these patients, CMV can lead to graft failure, multiorgan disease, increased risk of other infections, GVHD, post-transplant lymphoproliferative disorders, and higher transplant-related mortality (TRM). Although antiviral prophylaxis, CMV infection occurs in 38-80% of HSCT recipients, but current antiviral drugs are insufficiently effective and they are associated with adverse effects. Furthermore, treatment failure is due to the high genetic variability of CMV. The protective role of virus-specific antibodies remains under debate. Some studies suggest that high neutralizing antibody titers protect transplant recipients from CMV, while others highlight the importance of T-cell responses. However, recent animal studies showed that humoral immunity alone can prevent CMV reactivation, even without T or NK cells. In solid-organ transplant patients, antibody titers ≥480 have been linked to reduced infection, shorter treatment, and full protection from CMV disease. Although the use of anti-CMV immunoglobulin remains controversial, the IRCCS Burlo Garofolo has used it as post-transplant prophylaxis and second-line treatment for over a decade. The main objective of their study was to assess whether CMV-specific immunoglobulin prophylaxis reduces CMV incidence and severity in pediatric HSCT patients. Secondary goals included evaluating its effect on transplant outcomes and its efficacy across different ethnic groups. A population pharmacokinetic (POP/PK) study was also conducted to better understand the drug's distribution and elimination and to identify factors influencing its pharmacokinetics in patients.
Eligibility Criteria
Inclusion Criteria: * Children who underwent allogeneic HSCT due to any condition Exclusion Criteria: * Positive personal records of immunoglobulin-related adverse reactions * CMV reactivation before the CMV-specific immunoglobulin prophylaxis onset * adoptive cellular post-HSCT immunotherapy for any indication
Contact & Investigator
Natalia Maximova, MD
PRINCIPAL INVESTIGATOR
IRCCS Burlo Garofolo - Trieste - ITALY
Frequently Asked Questions
Who can join the NCT07013370 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Immunoglobulin Prophylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07013370 currently recruiting?
Yes, NCT07013370 is actively recruiting participants. Contact the research team at natalia.maximova@burlo.trieste.it for enrollment information.
Where is the NCT07013370 trial being conducted?
This trial is being conducted at Trieste, Italy.
Who is sponsoring the NCT07013370 clinical trial?
NCT07013370 is sponsored by Antonello Di Paolo, M.D., Ph.D.. The principal investigator is Natalia Maximova, MD at IRCCS Burlo Garofolo - Trieste - ITALY. The trial plans to enroll 150 participants.