Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05432778




Registration number
NCT05432778
Ethics application status
Date submitted
20/06/2022
Date registered
27/06/2022

Titles & IDs
Public title
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients
Scientific title
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study
Secondary ID [1] 0 0
01
Universal Trial Number (UTN)
Trial acronym
CYPHER-TXPilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CMV Viremia 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Letermovir Pill

Experimental: Study Group - All patients in the Study Group will receive virostatic prophylaxis with letermovir 480 mg qd (We will be utilizing Letermovir oral formulation of 240 mg or 480 mg as available).

No intervention: Control Group - Patients in Controls will receive standard-of-care virostatic prophylaxis with valgancyclovir 450 mg bid.


Treatment: Drugs: Letermovir Pill
Patients in the Study Group will receive virostatic prophylaxis with letermovir 480 mg qd (We will be utilizing Letermovir oral formulation of 240 mg or 480 mg as available). n all patients the virostatic prophylaxis will be initiated between days 4 and 7 after heart transplantation and the duration of virostatic prophylaxis will be determined by the Quantiferon-CMV assay.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The rate of early CMV infections/disease during virostatic prophylaxis.
Timepoint [1] 0 0
baseline - 12 months
Secondary outcome [1] 0 0
The rate of leukopenia during virostatic prophylaxis
Timepoint [1] 0 0
baseline - 12 months
Secondary outcome [2] 0 0
The rate of neutropenia during virostatic prophylaxis
Timepoint [2] 0 0
baseline - 12 months
Secondary outcome [3] 0 0
The rate of late CMV infections/disease between virostatic discontinuation and 6 months thereafter.
Timepoint [3] 0 0
baseline - 12 months
Secondary outcome [4] 0 0
The time-course of the restitution of cell-mediated immunity during virostatic prophylaxis
Timepoint [4] 0 0
baseline - 12 months
Secondary outcome [5] 0 0
The rate of CMV resistance to virostatic therapy
Timepoint [5] 0 0
baseline - 12 months

Eligibility
Key inclusion criteria
* heart transplant recipient (new)
* moderate (D+/R+ and D-/R+) or high (D+/R-) risk CMV serostatus
* signed informed consent for participation in the study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* short-term mechanical circulatory support prior HTX
* ongoing CMV infection/disease
* D-/R- CMV serostatus
* heart re-transplantation
* need for intensified immunosuppression protocol

* >20% cytolytic alloantibodies prior transplant
* perioperative (within 7 days after HTX) allograft rejection > 1R
* immunoinduction with ATG
* pregnancy
* active participation in another interventional clinical trial
* know hypersensitivity to letermovir
* known hypersensitivity to valgancyclovir
* known hematological disorders (apart from anemia)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Slovenia
State/province [1] 0 0
Ljubljana

Funding & Sponsors
Primary sponsor type
Other
Name
University Medical Centre Ljubljana
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bojan Vrtovec, MD, PhD
Address 0 0
Advanced Heart Failure and Transplantation Center, Universtiy Medical Center Ljubljana, Slovenia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bojan Vrtovec, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+38615222844
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05432778