A study to determine how safe and effective maribavir versus Valganciclovir is in treating cytomegalovirus(CMV) in transplant patients

Phase 1

• Conditions: CMV INFECTIONS IN TRANSPLANT RECIPIENTS; MedDRA version: 16.1Level: LLTClassification code 10021819Term: Infection in marrow transplant recipientsSystem Organ Class: 100000004862; MedDRA version: 16.1Level: LLTClassification code 10021829Term: Infection in solid organ transplant recipientsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024247-32-DE
• Lead Sponsor: VIROPHARMA INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-07
• Study Completion: 2014-07-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1. Be =18 years of age.
2. Be a recipient of stem cell or solid organ transplantation.
3. Have documented CMV infection in blood or plasma, with a screening value of =1,000 to =100,000 DNA copies/mL as determined by quantitative PCR or comparable quantitative CMV assay type. Results from either the central laboratory or a local laboratory can be used for qualification.
4. Have CMV infection that does not meet the definition of CMV organ disease at the time of enrollment (see Appendix IV).
5. Have a CMV infection that is not known to be resistant to ganciclovir/valganciclovir, foscarnet, or cidofovir based on genotypic evidence.
6. Have all of the following findings as part of screening laboratory assessment (results from either the central laboratory or a local laboratory can be used for qualification):
• Absolute neutrophil count (ANC =500/mm3 [0.5 x 109/L]
• Platelet count =25,000/mm3 [25 x 109/L]
• Hemoglobin =8 g/dL
7. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test as part of screening laboratory assessments (pregnancy test results from either the central laboratory or a local laboratory can be used for qualification). Women of child bearing potential also must agree to use an acceptable method of birth control, as determined by the investigator, during the study drug administration period and for 3 months afterward. Hormonal contraceptives should not be used as the sole method of birth control.
If male, must agree to use an acceptable method of birth control, as determined by
the investigator, during the study drug administration period and for 3 months afterward.
8. Be able to swallow tablets.
9. Be informed of the nature of the study and provide written informed consent
before any study-specific procedures are performed. [NOTE: Subjects must be
fully able to give their consent.]
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Subjects must not:
1. Be receiving any of the following therapies when study drug is initiated:
• ganciclovir
• valganciclovir
• foscarnet
• cidofovir
• CMV immune globulin (CMV-IGIV, Cytogam®)
• leflunomide
• artesunate
NOTE: A subject may have received any of the above listed drugs prior to enrollment. If this is the case, these drugs must be discontinued, and a washout” period of =24 hours is required between the last dose and commencement of dosing with study drug.
2. Have known allergies to one of the study medications (e.g., valganciclovir) or its excipients.
3. Have estimated creatinine clearance (CrCl) <10 mL/min or require dialysis when
study drug is initiated.
4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study drug that would preclude administration of oral/enteral medication.
5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
6. Have any serious illness with expected survival less than 6 weeks.
7. Be pregnant (as determined by ß-human chorionic gonadotropin testing prior to
initiation of study drug) or breastfeeding.
8. Have received any investigational (unapproved) agent with known anti-CMV
activity within 30 days before initiation of study drug.
9. Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug or interpretation of study results, or compromise the safety or wellbeing of the subject.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified