- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
California
-
Los Angeles, California, Forente stater, 90095-8358
- Ronald Reagan University of California Los Angeles Medical Center
-
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Georgia
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Atlanta, Georgia, Forente stater, 30322-1013
- Emory Clinic - Transplant Center
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Minnesota
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Rochester, Minnesota, Forente stater, 55905-0001
- Mayo Clinic, Rochester - Infectious Diseases
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New York
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New York, New York, Forente stater, 10029-6504
- Mount Sinai School of Medicine - Medicine - Infectious Diseases
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213-3403
- University of Pittsburgh - Medicine - Infectious Diseases
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-
Washington
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Seattle, Washington, Forente stater, 98195-7110
- University of Washington - Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
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.
|
Aktiv komparator: Prophylaxis
900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation.
All dosages adjusted for renal dysfunction.
n=88
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of Cytomegalovirus (CMV) Disease.
Tidsramme: 365 days post-transplant
|
CMV disease as verified by an independent end point committee
|
365 days post-transplant
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
All-cause Mortality
Tidsramme: Up to 365 days post-transplant
|
Survival probability at 1 year
|
Up to 365 days post-transplant
|
Incidence of Allograft Rejection
Tidsramme: Up to 365 days post-transplant
|
Number of subjects with allograft rejection
|
Up to 365 days post-transplant
|
Graft Loss
Tidsramme: Up to 365 days post-transplant
|
Incidence of graft loss (re-transplantation)
|
Up to 365 days post-transplant
|
Late-onset CMV Disease
Tidsramme: Up to 365 days post-transplant
|
Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
|
Up to 365 days post-transplant
|
Bacterial Infections
Tidsramme: Up to 365 days post-transplant
|
Incidence of bacterial opportunistic infections
|
Up to 365 days post-transplant
|
Major Fungal Infections
Tidsramme: Up to 365 days post-transplant
|
Opportunistic fungal infections
|
Up to 365 days post-transplant
|
Major Non-CMV Viral Infections
Tidsramme: Up to 365 days post-transplant
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Incidence of non-CMV viral infections
|
Up to 365 days post-transplant
|
Neutropenia
Tidsramme: Day 1 through Day 107
|
Incidence of neutropenia less than 1000/µL while on valganciclovir treatment
|
Day 1 through Day 107
|
Neutropenia Less Than 500
Tidsramme: prior to day 107
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ANC less than 500 while on valganciclovir
|
prior to day 107
|
Hematopoietic Growth Factors
Tidsramme: Day 1 through Day 107
|
Hematopoietic growth factor receipt for ANC less than 500 during valganciclovir treatment.
|
Day 1 through Day 107
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-0073
Legemiddel- og utstyrsinformasjon, studiedokumenter
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