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- Klinische proef NCT01552369
CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095-8358
- Ronald Reagan University of California Los Angeles Medical Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322-1013
- Emory Clinic - Transplant Center
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905-0001
- Mayo Clinic, Rochester - Infectious Diseases
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New York
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New York, New York, Verenigde Staten, 10029-6504
- Mount Sinai School of Medicine - Medicine - Infectious Diseases
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213-3403
- University of Pittsburgh - Medicine - Infectious Diseases
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Washington
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Seattle, Washington, Verenigde Staten, 98195-7110
- University of Washington - Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Be > / = 18 years of age.
- Have negative Cytomegalovirus (CMV) serology (confirmed within 6 months of transplant) and receive a liver from a donor with positive CMV serology (R-/D+).
- Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
- Have absolute neutrophil count > 1000/µL at randomization.
- If female, and not postmenopausal or surgically sterile, must have negative pregnancy test (serum or urine) within 48 hours prior to randomization and must also agree to use medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence for 100 days after randomization and 3 months after valganciclovir cessation.
-- If male, and has not had a vasectomy, he must agree to practice barrier method of contraception for 100 days after randomization and 3 months after valganciclovir cessation.
- Subject or legally authorized representative has provided written informed consent.
Exclusion Criteria:
- Currently enrolled in any interventional trial of an investigational therapeutic agent unless co-enrollment has been approved by study Principal Investigators (PIs) and the DMID prior to enrollment.
- Have hypersensitivity to acyclovir, ganciclovir or valganciclovir.
- Be breast-feeding mother.
- Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
- Be undergoing multi organ transplant or have undergone prior organ transplant.
- Have expected life expectancy of less than 72 hours.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Preemptive Therapy
900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test.
All dosages adjusted for renal dysfunction.
n=88
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Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 100 days post transplantation as prophylaxis.
Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
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Actieve vergelijker: Prophylaxis
900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation.
All dosages adjusted for renal dysfunction.
n=88
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Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 100 days post transplantation as prophylaxis.
Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Incidence of Cytomegalovirus (CMV) Disease.
Tijdsspanne: 365 days post-transplant
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CMV disease as verified by an independent end point committee
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365 days post-transplant
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
All-cause Mortality
Tijdsspanne: Up to 365 days post-transplant
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Survival probability at 1 year
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Up to 365 days post-transplant
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Incidence of Allograft Rejection
Tijdsspanne: Up to 365 days post-transplant
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Number of subjects with allograft rejection
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Up to 365 days post-transplant
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Graft Loss
Tijdsspanne: Up to 365 days post-transplant
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Incidence of graft loss (re-transplantation)
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Up to 365 days post-transplant
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Late-onset CMV Disease
Tijdsspanne: Up to 365 days post-transplant
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Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
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Up to 365 days post-transplant
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Bacterial Infections
Tijdsspanne: Up to 365 days post-transplant
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Incidence of bacterial opportunistic infections
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Up to 365 days post-transplant
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Major Fungal Infections
Tijdsspanne: Up to 365 days post-transplant
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Opportunistic fungal infections
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Up to 365 days post-transplant
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Major Non-CMV Viral Infections
Tijdsspanne: Up to 365 days post-transplant
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Incidence of non-CMV viral infections
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Up to 365 days post-transplant
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Neutropenia
Tijdsspanne: Day 1 through Day 107
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Incidence of neutropenia less than 1000/µL while on valganciclovir treatment
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Day 1 through Day 107
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Neutropenia Less Than 500
Tijdsspanne: prior to day 107
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ANC less than 500 while on valganciclovir
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prior to day 107
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Hematopoietic Growth Factors
Tijdsspanne: Day 1 through Day 107
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Hematopoietic growth factor receipt for ANC less than 500 during valganciclovir treatment.
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Day 1 through Day 107
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Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, Limaye AP. Risk Factors for Cytomegalovirus Viremia following Liver Transplantation With a Seropositive Donor and Seronegative Recipient Receiving Antiviral Therapy. J Infect Dis. 2021 Mar 29;223(6):1073-1077. doi: 10.1093/infdis/jiaa470.
- Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, Stevens-Ayers T, Edmison B, Boeckh M, Limaye AP. Effect of Preemptive Therapy vs Antiviral Prophylaxis on Cytomegalovirus Disease in Seronegative Liver Transplant Recipients With Seropositive Donors: A Randomized Clinical Trial. JAMA. 2020 Apr 14;323(14):1378-1387. doi: 10.1001/jama.2020.3138.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11-0073
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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Klinische onderzoeken op Cytomegalovirus-infectie
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ModernaTX, Inc.Actief, niet wervendCytomegalovirusVerenigd Koninkrijk, Verenigde Staten, Canada
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CMV Research FoundationInternational AIDS Vaccine InitiativeVoltooidCytomegalovirusVerenigde Staten
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University of Wisconsin, MadisonVoltooidCytomegalovirusVerenigde Staten
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University Hospital, LimogesVoltooid
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University Hospital, LimogesVoltooid
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Beckman Coulter, Inc.Beëindigd
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National Taiwan University HospitalOnbekendCytomegalovirus EndotheliitisTaiwan
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Mackay Memorial HospitalVoltooidKanker | CytomegalovirusTaiwan
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Hadassah Medical OrganizationVoltooidCytomegalovirus | Beenmerg transplantatieIsraël
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Mayo ClinicVoltooidCytomegalovirus-infectieVerenigde Staten
Klinische onderzoeken op Valganciclovir
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Luis Eduardo Morales BuenrostroVoltooidNiertransplantatie | Farmacokinetiek | Cytomegalovirusinfecties | Therapeutische gelijkwaardigheidMexico
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Stanford UniversityVoltooidChronisch vermoeidheidssyndroomVerenigde Staten
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GenVivo, Inc.WervingVaste tumor, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Weill Medical College of Cornell University; University... en andere medewerkersVoltooidSarcoomVerenigde Staten
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Rabin Medical CenterVoltooidInfectie bij ontvangers van orgaantransplantatiesIsraël
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University of California, San FranciscoRoche Pharma AGVoltooidHIV-infecties | CytomegalovirusinfectiesVerenigde Staten
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Dr. Reddy's Laboratories LimitedVoltooid
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Dr. Reddy's Laboratories LimitedVoltooid
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Scott PalmerRoche Pharma AGVoltooidCytomegalovirusinfectiesVerenigde Staten
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Karolinska InstitutetKarolinska University HospitalVoltooidGlioblastoom Multiforme | Cytomegalovirus-infectieZweden