CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Maribavirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05137717
NCT05137717Phase 3Completed

A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)

Takeda·interventional·Posted Nov 30, 2021·Updated Jul 9, 2024

In Brief

A Phase 3 clinical trial evaluating Maribavir for Cytomegalovirus (CMV). Completed, enrolled 41 participants across 20 sites.

Detailed Summary

The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 30, 2021
Enrollment StartJan 18, 2022
Primary CompletionJun 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.6 years ago

Interventions

Maribavirdrug

Maribavir tablets