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The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.
The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.
Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants who have received maribavir treatment for the approved indication after marketing authorization (de novo participants) and before marketing authorization (legacy participants) under expanded access type of program or compassionate use in the real-world setting. Data will be collected prospectively and/or retrospectively from the medical records during this observational period of 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is non-interventional study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs will include both serious and non-serious AEs. | From start of treatment up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16 | CMV viremia clearance will be defined as CMV DNA concentration below the lower limit of considered by each local site for clearance according to real-world clinical practice. | At Weeks 8 and 16 |
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Inclusion Criteria:
Exclusion Criteria
- There are no specific exclusion criteria.
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Adult and pediatric participants with post-transplant CMV infection/disease that are refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet, that are treated with maribavir according to approved indications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IC Projects | Recruiting | City of Buenos Aires | C11119ACN | Argentina |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16 | CMV infection symptom control will be defined as resolution or improvement CMV disease/syndrome for participants symptomatic at baseline, or absence of the development of CMV disease/syndrome or participants asymptomatic at baseline. | At Weeks 8 and 16 |
| Percentage of Participants Who Achieved a Clinically Relevant Response Regardless of Whether Treatment was Discontinued Before 8 weeks of Therapy | Clinically relevant response will be defined as no need for the use of an antiviral at a therapeutic dose for at least 4 weeks after completing treatment with maribavir, due to clinical improvement (improvement of CMV-related symptoms or the absence of these in the case of asymptomatic infections) and virological improvement (decrease of at least 1 log of viremia during treatment with maribavir). | Up to Week 8 |