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A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea

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Takeda

Status

Not yet enrolling

Conditions

Cytomegalovirus (CMV)

Treatments

Drug: LIVTENCITY

Study type

Observational

Funder types

Industry

Identifiers

NCT06555432
TAK-620-4002

Details and patient eligibility

About

Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea.

The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting.

During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.

Enrollment

168 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
  • Participants with age greater than or equal to (>=) 19 years.
  • Initiate first treatment course with maribavir.
  • Voluntarily consent to participate in the study.

Exclusion criteria

  • Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
  • Participants previously treated with maribavir in any study or as marketed drug.
  • Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.

Trial design

168 participants in 1 patient group

All Participants
Description:
Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy (including ganciclovir, valganciclovir, foscarnet or cidofovir) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period.
Treatment:
Drug: LIVTENCITY

Trial contacts and locations

0

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Central trial contact

Takeda Contact

Data sourced from clinicaltrials.gov

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