Health TrialsbyHealthPanel

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

ConditionCytomegalovirus Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Weight ≥ 30 kg

Kidney transplant recipient

Have a documented CMV infection or disease, with (i) a screening value of CMV DNA ≥ 3000 IU/mL in whole blood or plasma in 2 consecutive assessments separated by ≥ 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR). Both samples should be taken within 14 days prior to randomization with the second sample obtained within 5 days prior to randomization OR (ii) a screening value of CMV DNA ≥ 30000 IU/mL in whole blood or plasma, as determined by local laboratory quantitative polymerase chain reaction (qPCR), in 1 sample obtained within 5 days prior to randomization

Disqualifiers

Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to antiviral treatment, to the best knowledge of the investigator.

Have a CMV infection that is known to be genotypically resistant to valganciclovir and/or letermovir on documented evidence.

Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir or maribavir) for the current CMV infection for longer than 72 hours. However, patients experiencing CMV infection while receiving ganciclovir or valganciclovir prophylaxis (i.e. at prophylactic dosages) or letermovir prophylaxis can be included.

Have an eGFR < 15 mL/min/1.73m² (using the CKD-EPI Creatinine Equation (2009)).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letermovir

    Drug

    480mg (2X240mg- tablets) of Letermovir given orally once a day until the "treatment success" or the "treatment failure", up to 12 weeks. In case of co-administration with cyclosporine A, the dosage of Letermovir will be reduced.

  • Valganciclovir

    Drug

    Valganciclovir 900 mg (2X450 mg-tablets) twice a day until the "treatment success" or the "treatment failure", up to 12 weeks. In case of impaired renal function, the dosage of valganciclovir will be reduced.

  • Letermovir placebo

    Drug

    480mg (2X240mg- tablets) of Letermovir placebo given orally once a day until the "treatment success" or the "treatment failure", up to 12 weeks

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Letermovir+ValganciclovirExperimental treatment 2 interventions
Group B: Letermovir Placebo+ValganciclovirActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Virological response to treatment on week-3

defined as a ≥ 2 log10 decrease of CMV DNAemia in whole blood from baseline, or an undetectable CMV DNAemia (\< 200 IU/mL) in whole blood

Time frame
3 weeks

Secondary outcomes

1

Eradication of CMV DNAemia (< 200 IU/ml) before Week-12

quantitative CMV PCR performed in whole blood every week until interruption of antiviral treatment, or at the latest until Week-12

Time frame
12 weeks
2

Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL

Quantitative CMV PCR performed in whole blood every week until interruption of antiviral treatment, or at the latest until Week-12

Time frame
12 weeks
3

Absence of CMV-related disease or syndrome at baseline and each visit

Time frame
12 weeks
4

Adverse event (AE) occurence

Clinical examination and clinical laboratory assessments performed every week until interruption of antiviral treatment (or at the latest until Week-12)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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