- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00686543
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
9 mars 2017 uppdaterad av: Merck Sharp & Dohme LLC
A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
75
Fas
- Fas 4
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects >=18 years of age
- High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.
- High risk of invasive fungal infection (IFI) based on anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm^3 [0.5 x 10^9/L]).
- Clinical laboratory safety tests within normal limits or clinically acceptable to the investigator or sponsor.
- Free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the study evaluations.
- Subjects must be willing to give written informed consent and able to adhere to dosing, study visit schedule, and mandatory procedures.
Exclusion Criteria:
- Female subjects who are pregnant, intend to become pregnant, or are nursing.
- Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days of Enrollment (ie, voriconazole, fluconazole [FLU], or itraconazole [ITZ]).
- Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to enrollment. (Subjects who are receiving either voriconazole or micafungin for prophylaxis against IFI should discontinue those therapies upon enrollment.)
- Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.
- Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.
- Subjects who must take prohibited medications during the study.
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
- Subjects who are part of the staff personnel directly involved with this study.
- Subjects who are a family member of the investigational study staff.
- Prior enrollment in this study.
- Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status >2 prior to induction chemotherapy for their underlying disease.
- Subjects with proven or probable invasive or systemic fungal infection at Baseline.
- Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15
POS 200 mg three times a day (TID) on Days 1-8 followed by continued randomized dosing regimen of POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
|
Posaconazole will be used for prophylaxis
Andra namn:
|
Experimentell: POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15
POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg twice a day (BID) on Days 9-15, administered with food or oral nutritional supplements.
|
Posaconazole will be used for prophylaxis
Andra namn:
|
Experimentell: POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15
POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
|
Posaconazole will be used for prophylaxis
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean POS Plasma Concentrations on Days 2, 3, and 8.
Tidsram: Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8
|
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8
|
Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen
Tidsram: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8
Tidsram: Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8
Tidsram: Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15
Tidsram: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15
Tidsram: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2007
Primärt slutförande (Faktisk)
1 april 2009
Avslutad studie (Faktisk)
1 april 2009
Studieregistreringsdatum
Först inskickad
27 maj 2008
Först inskickad som uppfyllde QC-kriterierna
29 maj 2008
Första postat (Uppskatta)
30 maj 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Hematologiska sjukdomar
- Bakteriella infektioner och mykoser
- Agranulocytos
- Leukopeni
- Leukocytstörningar
- Leukemi
- Infektioner
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Mykoser
- Neutropeni
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Hormoner, hormonsubstitut och hormonantagonister
- Cytokrom P-450 enzymhämmare
- Hormonantagonister
- Antifungala medel
- Steroidsyntesinhibitorer
- Antiprotozomedel
- Antiparasitära medel
- 14-alfa-demetylasinhibitorer
- Trypanocidala medel
- Posakonazol
Andra studie-ID-nummer
- P05115
- EudraCT No. 2007-003148-31
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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-
Institut PasteurRekrytering
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Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
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Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
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Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
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National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
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National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
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Boston Children's HospitalSterileCare Inc.Anmälan via inbjudanCentral Line komplikation | Central Line-associated Bloodstream Infection (CLABSI)Förenta staterna
Kliniska prövningar på Posaconazole
-
Universitätsklinikum Hamburg-EppendorfAvslutadKritisk sjukdom | Terapeutisk läkemedelsövervakningTyskland
-
Cedars-Sinai Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekryteringCrohns sjukdom | CARD9 S12N RiskallelFörenta staterna