- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00942305
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Ability of CMX001 to Prevent or Control CMV Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- The University of Alabama at Birmingham
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California
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La Jolla, California, Vereinigte Staaten, 92093
- Moores UCSD Cancer Center
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Los Angeles, California, Vereinigte Staaten, 90095
- UCLA Medical Center
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Denver
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Winship Cancer Institute at Emory University
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637
- University of Chicago Medical Center
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Womens Hospital, Division of Infectious Disease
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan Medical School
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Detroit, Michigan, Vereinigte Staaten, 48201
- Harper University Hospital
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- University of Minnesota Medical Center
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68198-5130
- Nebraska Medical Center
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New Jersey
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Hackensack, New Jersey, Vereinigte Staaten, 07601
- Hackensack University Medical Center
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New York
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Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center Oncology
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New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Vereinigte Staaten, 10029
- Mt. Sinai School of Medicine
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Rochester, New York, Vereinigte Staaten, 14642
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- UNC Health Care Center
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, Vereinigte Staaten, 27517
- Wake Forest University School of Medicine
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- The Cleveland Clinic
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
- Oregon Health and Science University
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Texas
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Dallas, Texas, Vereinigte Staaten, 75246
- Baylor University Medical Center
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Dallas, Texas, Vereinigte Staaten, 75390-8565
- UT Southwestern Medical Center at Dallas
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Houston, Texas, Vereinigte Staaten, 77030
- University of Texas, MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84088
- Utah Cancer Specialists - Intermountain Healthcare
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Washington
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Seattle, Washington, Vereinigte Staaten, 98109
- Fred Hutchinson Cancer Research Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
For inclusion into the study, all prospective subjects were required to fulfill all of the following criteria (as applicable):
- Were aged ≥18 years. Males must have been able and willing to use adequate contraceptive methods throughout the treatment and follow-up phases of the study.
- Were cytomegalovirus (CMV) seropositive before allogeneic hematopoietic stem cell transplantation (HCT) (i.e., R+ subjects).
- Were less than 30 days post qualifying transplant.
- Had evidence of engraftment before randomization and receiving their first dose of study drug.
- Were able to ingest and absorb oral medication (in the judgment of the investigator and based on lack of significant gastrointestinal [GI] events).
- Were willing and able to understand and provide written informed consent.
- To the best of his or her knowledge, were willing and able to participate in all required study activities for the duration of the study.
Exclusion Criteria
Subjects meeting any of the following exclusion criteria were to be excluded from participation in the study:
- Females who were pregnant or currently nursing.
- Had a body mass index >35 kg/m2. [Note: This criterion was removed per Protocol Amendment 2 dated 27 August 2010.]
- Had hypersensitivity to cidofovir (CDV) or brincidofovir.
- Recipients for whom the current, predose clinical course of CMV infection suggested that the investigator would not be able to withhold treatment for CMV for a minimum of 5, but preferably 7 days following the subject's first dose of study drug.
Received any of the following:
- Ganciclovir, valganciclovir, foscarnet or CDV within 14 days prior to enrollment;
- Any anti-CMV therapy following transplantation (including Cytogam®1);
- Any CMV vaccine;
- Any investigational drug with antiviral activity against double-stranded DNA (dsDNA) viruses within 14 days prior to enrollment. [Note: An investigational drug was defined as a drug that was not approved for any indication by the Food and Drug Administration.]; or
- Any other investigational drug (i.e., those without any "anti-dsDNA virus" activity; e.g., anti-influenza compounds) within 14 days prior to enrollment without the prior written consent of the medical monitor. The use of investigational drugs in certain circumstances was added per Protocol Amendment 1 dated 15 January 2010.
- Received high dose acyclovir (>2000 mg total oral daily dose or >5 mg/kg intravenously 3 times daily) or valacyclovir (Valtrex; >3000 mg total daily dose) at the time of dosing.
- Were diagnosed with active CMV disease within 6 months prior to enrollment; patients with CMV DNAemia requiring intervention with antiviral therapy at the time of enrollment.
- Were HIV positive; patients with active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection as evidenced by plasma levels of HCV RNA or HBV DNA, respectively.
- Received another allogeneic HCT within the past 2 years, other than the qualifying HCT.
- Had renal insufficiency as evidenced by glomerular filtration rate (GFR) <30 mL/min.
- Had a current diagnosis of hypotony, uveitis, or retinitis or any intraocular pathology that would predispose the subject to any one of these conditions.
- Had hepatic dysfunction as evidenced by alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of normal (ULN) or direct bilirubin >2.5 x the ULN.
- Had any of the following active autoimmune disorders: myasthenia gravis, Addison's disease, Wegener's granulomatosis, primary biliary cirrhosis, bullous pemphigoid, autoimmune hemolytic anemia, autoimmune hepatitis, multiple sclerosis, Goodpasture's syndrome, idiopathic thrombocytopenic purpura, lupus erythematosus, dermatomyositis, polymyositis, or vasculitis.
- Had active solid tumor malignancies with the exception of basal cell carcinoma or the condition under treatment (e.g., lymphomas).
- Had 1 or more episode of hyperglycemic coma or diabetic ketoacidosis within the 6 months prior to enrollment.
- Had cardiovascular disease which, in the opinion of the investigator, would interfere with the conduct of the study.
- Had Grade 3 or 4 graft versus host disease of the GI tract; subjects with any GI disease that would, in the judgment of the investigator, preclude the subject from taking or absorbing oral medication (e.g. clinically active Crohn's disease, ischemic colitis, moderate or severe ulcerative colitis, or any condition expected to require abdominal surgery during the course of study participation).
- Any other condition including abnormal laboratory values that would have, in the judgment of the investigator, put the subject at increased risk for participating in the trial, or interferes with the conduct of the trial.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: Placebo
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Subjects received their first dose of study drug within 30 (+5) days post-transplant and were treated through Week 13 post-transplant. Matching placebo administered for each cohort. |
Experimental: Brincidofovir
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Subjects received their first dose of study drug of brincidofovir (BCV) within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants With Clinically Significant CMV Infection
Zeitfenster: Randomization to Week 8 post-treatment (~19 weeks)
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The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia >200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.
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Randomization to Week 8 post-treatment (~19 weeks)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Lanier ER, Foster S, Brundage T, Chou S, Prichard MN, Kleiboeker S, Wilson C, Colville D, Mommeja-Marin H. Analysis of Mutations in the Gene Encoding Cytomegalovirus DNA Polymerase in a Phase 2 Clinical Trial of Brincidofovir Prophylaxis. J Infect Dis. 2016 Jul 1;214(1):32-5. doi: 10.1093/infdis/jiw073. Epub 2016 Mar 3.
- Marty FM, Winston DJ, Rowley SD, Vance E, Papanicolaou GA, Mullane KM, Brundage TM, Robertson AT, Godkin S, Mommeja-Marin H, Boeckh M; CMX001-201 Clinical Study Group. CMX001 to prevent cytomegalovirus disease in hematopoietic-cell transplantation. N Engl J Med. 2013 Sep 26;369(13):1227-36. doi: 10.1056/NEJMoa1303688.
- Tippin TK, Morrison ME, Brundage TM, Mommeja-Marin H. Brincidofovir Is Not a Substrate for the Human Organic Anion Transporter 1: A Mechanistic Explanation for the Lack of Nephrotoxicity Observed in Clinical Studies. Ther Drug Monit. 2016 Dec;38(6):777-786. doi: 10.1097/FTD.0000000000000353.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CMX001-201
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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