EUCTR2019-002233-11-ES
Active, Not Recruiting
Phase 1
The proposed study is a phase IV, randomized, controlled, multicenter and open clinical trial, with two parallel groups, to evaluate the effectiveness of a preventive strategy against CMV infection in heart transplant patients with positive serology against CMV based on T cells responses to IE-1 and pp65 CMV antigens, determined by ELISPOT IFN-? assay - ELISPOT-TC
Dr. José González Costello.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco. Hospital Univ. Bellvitge0 sites188 target enrollmentDecember 2, 2019
ConditionsWe will investigate the benefits of monitoring the CMV-specific cellular response using the ELISPOT INF-y technique in patients with a positive serology against CMV, allowing the individualization of the preventión strategy. The drugs valganciclovir and ganciclovir will be used in seropositive patitens (IgG against CMV), not indicated in the data sheet but accepted as part of the habitual prophylaxis of heart transplant patient according to the clinical practice guidelines.MedDRA version: 20.0 Level: LLT Classification code 10058666 Term: Cytomegalovirus infection reactivation System Organ Class: 100000004862Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- We will investigate the benefits of monitoring the CMV-specific cellular response using the ELISPOT INF-y technique in patients with a positive serology against CMV, allowing the individualization of the preventión strategy. The drugs valganciclovir and ganciclovir will be used in seropositive patitens (IgG against CMV), not indicated in the data sheet but accepted as part of the habitual prophylaxis of heart transplant patient according to the clinical practice guidelines.
- Sponsor
- Dr. José González Costello.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco. Hospital Univ. Bellvitge
- Enrollment
- 188
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adult patients (18 years or more), both sexes, heart transplant patients.
- •2\) Patients with positive IgG against CMV (seropositive).
- •3\) Informed consent given by the subject or his legal representative.
- •4\) Availability of obtaining recipient and donor serologies.
- •5\) Women of childbearing age who use effective contraceptive methods during and for at least 30 days after treatment. Men who use barrier contraceptive methods during and for at least 90 days after treatment, unless there is certainty that the female partner can’t get pregnant.
- •6\) Availability of obtaining biological samples of peripheral blood post\-transplant to be able to perform the ELISPOT IFN\-? assay.
- •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 100
Exclusion Criteria
- •1\) Pregnancy and / or lactation.
- •2\) Patients with biological samples in poor condition at visit 2 (at 10 days post\-HT) that prevent the determination of immunological tests.
- •3\) Patients receiving thymoglobulin as induction therapy.
- •4\) Patients with contraindication for the use of ganciclovir or valganciclovir.
Outcomes
Primary Outcomes
Not specified
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