Maribavir for CMV Infection

Recruiting at 65 trial locations

Overseen By Takeda Contact

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must not be taking: Valganciclovir, Ganciclovir, others

Disqualifiers: CNS CMV, Severe liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate before starting the study treatment. If you are on any of these, you will need to stop them before participating.

What data supports the effectiveness of the drug Maribavir for CMV infection?

Research shows that Maribavir can reduce the incidence of CMV infection in transplant recipients compared to a placebo, with fewer patients needing additional anti-CMV therapy. It also does not cause myelosuppression (a decrease in bone marrow activity) like some other treatments. ^{1 2 3 4 5}

How is the drug Maribavir unique in treating CMV infections?

Maribavir is unique because it works by inhibiting a specific enzyme (pUL97 kinase) that the cytomegalovirus (CMV) needs to replicate, making it effective even against CMV strains resistant to other treatments. It is taken orally and is rapidly absorbed, providing an alternative for patients who do not respond to standard antiviral drugs like ganciclovir or foscarnet. ^{1 3 5 6 7}

What is the purpose of this trial?

The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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.

Inclusion Criteria

I have a confirmed CMV infection with specific test results.

Have life expectancy of >= 8 weeks.

I am under 18 years old. If in Cohort 3, I was born full-term and weigh at least 5 kg.

Exclusion Criteria

I don't have any health issues that could affect the study or make it unsafe for me.

I do not have HIV, confirmed by a test within the last 3 months.

My body weight is low, affecting how much blood can be taken for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maribavir for the treatment of CMV infection

8 weeks

Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participants need to visit their doctor during this period

Treatment Details

Interventions

• Maribavir

Trial Overview 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.

Participant Groups

Group I: Cohort 3: Maribavir 400, 200, 100 or 50 mg Experimental Treatment 1 Intervention

Participants with 0 to \< 6 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg; or 50 mg powder for oral suspension BID based on body weight 7 to \< 10 kg; or 50 mg powder for oral suspension once daily (QD) based on body weight 5 to \<7 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).

Group II: Cohort 2: Maribavir 400, 200 or 100 mg Experimental Treatment 1 Intervention

Participants with \>= 6 to \< 12 years of age will receive maribavir 400 mg (2\*200 mg tablets or powder for oral suspension) BID based on body weight \>= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg orally for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).

Group III: Cohort 1: Maribavir 400, 200 or 100 mg Experimental Treatment 1 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 or powder for oral suspension) twice daily (BID) based on body weight \>= 25 kilogram (kg); or 200 mg tablet or powder for oral suspension BID based on body weight 14 to \< 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to \< 14 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8).

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Maribavir for the Management of Cytomegalovirus in Adult Transplant Recipients: A Review of the Literature and Practical Considerations. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety of Maribavir for the Treatment of Cytomegalovirus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Maribavir for Preemptive Treatment of Cytomegalovirus Reactivation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Maribavir: First Approval. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Maribavir: Mechanism of action, clinical, and translational science. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Maribavir sensitivity of cytomegalovirus isolates resistant to ganciclovir, cidofovir or foscarnet. [2018]