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Antiviral

Cohort 1: Maribavir 400 or 200 mg for Cytomegalovirus

Q: In how many distinct locations is this investigation currently being conducted?

The current trial operates across 21 different sites, including Omaha, Paris, and Würzburg among others. Opting for the nearest site would reduce travel obligations for potential participants.

Q: Are there any vacancies available for patients to participate in this trial?

Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment for this investigation. Initially published on November 13th, 2023, with the most recent update recorded on February 1st, 2024. The research aims to enroll a total of 80 participants distributed among 21 separate sites.

Q: What is the current capacity for patient enrollment in this clinical trial?

To proceed with the trial, we require 80 eligible participants. Takeda, the sponsor of this study, will oversee operations at various locations such as University of <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a> Medical Center in Omaha, Nebraska and Hopital Necker in Paris, Bayern.

Q: What are the anticipated results that researchers hope to achieve through this experimental investigation?

<ul> <li>Percentage of patients achieving Confirmed CMV viremia Clearance by Week 8</li> </ul>

Q: What is the safety profile of Cohort 1: Maribavir at doses of either 400 mg or 200 mg for individuals?

According to evaluations by our team at Power, the safety rating for Cohort 1 using Maribavir at either 400 mg or 200 mg is ranked as a level 3. This assessment aligns with the Phase 3 nature of the trial, indicating existing efficacy data and robust safety records from previous rounds.

Phase 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a documented CMV infection, with a CMV deoxyribonucleic acid (DNA) screening value of >= 1365 International Units per milliliter (IU/mL) in whole blood or >= 455 IU/mL in plasma in 2 consecutive assessments separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples must be taken within 14 days of first dose of study drug, with the second sample obtained within 5 days prior to first dose of study drug. The same laboratory and same sample type (whole blood or plasma) must be used for both assessments.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on day 7 (week 1); pre-dose on day 28 (week 4); pre-dose and 2 to 4 hours post-dose on day 56 (week 8)

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of maribavir in treating CMV infection in children and teenagers who have undergone stem cell or organ transplant. The study will also determine the best dosage

Who is the study for?

This trial is for children and teenagers under 18 who've had a solid organ or stem cell transplant, have CMV infection with specific blood test results, and whose transplants are working. They need to be healthy enough in terms of blood cells and kidney function, agree to birth control if applicable, and expect to live at least 8 more weeks.Check my eligibility

What is being tested?

The study tests the safety, tolerability, and proper dosing of Maribavir (an antiviral medication) in treating CMV infections in young transplant recipients. Participants will take Maribavir for 8 weeks with follow-up doctor visits over a subsequent 12-week period.See study design

What are the potential side effects?

While not specified here, common side effects of Maribavir may include taste disturbance, nausea, vomiting, diarrhea; less commonly it can affect blood counts or cause liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed CMV infection with specific test results.

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I have a confirmed CMV infection with specific test results.

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My blood counts and kidney function are within required ranges for the trial.

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I have had a solid organ or stem cell transplant that is currently working.

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My kidney function, based on a specific test, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on day 7 (week 1); pre-dose on day 28 (week 4); pre-dose and 2 to 4 hours post-dose on day 56 (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on day 7 (week 1); pre-dose on day 28 (week 4); pre-dose and 2 to 4 hours post-dose on day 56 (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on day 7 (week 1); pre-dose on day 28 (week 4); pre-dose and 2 to 4 hours post-dose on day 56 (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent Oral Clearance (CL/F) of Maribavir

Apparent Volume of Distribution (Vz/F) of Maribavir

Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir

+6 more

Secondary outcome measures

Change From Baseline in Log10 Plasma CMV Deoxyribonucleic Acid (DNA) Load

Number of Participants who Develop CMV Resistance to Maribavir

Percentage of Participants With Confirmed CMV viremia Clearance at Week 8

+5 more

Side effects data

From 2022 Phase 3 trial • 553 Patients • NCT02927067

53%

Neutropenia

23%

Thrombocytopenia

23%

Nausea

18%

Anaemia

17%

Vomiting

16%

Diarrhoea

12%

Acute graft versus host disease in skin

11%

Neutrophil count decreased

10%

Leukopenia

Pyrexia

Cough

Oedema peripheral

Hypokalaemia

Abdominal pain

Asthenia

Fatigue

Decreased appetite

Dysgeusia

Hypertension

Platelet count decreased

Pruritus

Dyspnoea

Headache

Renal impairment

Tremor

White blood cell count decreased

Blood creatinine increased

Constipation

Febrile neutropenia

Cystitis haemorrhagic

Taste disorder

Acute graft versus host disease in intestine

Acute lymphocytic leukaemia recurrent

Cytomegalovirus infection

Cytomegalovirus viraemia

Pneumonia

Pneumonia cytomegaloviral

Pseudomonal sepsis

Respiratory tract infection

Acute myeloid leukaemia recurrent

100%

80%

60%

40%

20%

Study treatment Arm

Valganciclovir 900 mg BID

Maribavir 400 mg BID

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: MaribavirExperimental Treatment1 Intervention

Participants with 0 to < 6 years of age will receive maribavir based on PK modeling.

Group II: Cohort 2: Maribavir 400 or 200 mgExperimental Treatment1 Intervention

Participants with >= 6 to < 12 years of age will receive maribavir 400 mg (2*200 mg tablets) BID based on body weight >= 25 kg or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.

Group III: Cohort 1: Maribavir 400 or 200 mgExperimental Treatment1 Intervention

Participants with greater than or equal to (>=) 12 to less than (<) 18 years of age will receive maribavir 400 milligrams (mg) (2*200 mg tablets) twice daily (BID) based on body weight >= 25 kilogram (kg) or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Maribavir

2017

Completed Phase 3

~1230

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,864 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,954 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,192 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct locations is this investigation currently being conducted?

"The current trial operates across 21 different sites, including Omaha, Paris, and Würzburg among others. Opting for the nearest site would reduce travel obligations for potential participants."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment for this investigation. Initially published on November 13th, 2023, with the most recent update recorded on February 1st, 2024. The research aims to enroll a total of 80 participants distributed among 21 separate sites."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"To proceed with the trial, we require 80 eligible participants. Takeda, the sponsor of this study, will oversee operations at various locations such as University of Nebraska Medical Center in Omaha, Nebraska and Hopital Necker in Paris, Bayern."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"- Percentage of patients achieving Confirmed CMV viremia Clearance by Week 8"

Answered by AI

What is the safety profile of Cohort 1: Maribavir at doses of either 400 mg or 200 mg for individuals?

"According to evaluations by our team at Power, the safety rating for Cohort 1 using Maribavir at either 400 mg or 200 mg is ranked as a level 3. This assessment aligns with the Phase 3 nature of the trial, indicating existing efficacy data and robust safety records from previous rounds."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection

2023. "A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05319353.

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