Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    2019-002267-10
Previous Study | Return to List | Next Study

Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218851
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to <18 years of age with invasive aspergillosis (IA).

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: Posaconazole IV Drug: Posaconazole PFS Drug: Posaconazole tablet Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Non-Comparative Clinical Trial to Study the Safety and Efficacy of Posaconazole (POS, MK-5592) in Pediatric Participants Aged 2 to Less Than 18 Years With Invasive Aspergillosis
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : February 6, 2023
Estimated Study Completion Date : February 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: Posaconazole
On Day 1 participants will receive two treatments of Posaconazole (POS)) 6 mg/kg body weight by intravenous (IV) infusion; on Days 2 through 7 participants will receive POS 6 mg/kg body weight once daily by IV infusion; beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on an IV formulation
Drug: Posaconazole IV
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Other Names:
  • MK-5592
  • SCH 056592
  • Noxafil®

Drug: Posaconazole PFS
POS PFS 6 mg/kg body weight taken orally
Other Names:
  • MK-5592
  • SCH 056592
  • Noxafil®

Drug: Posaconazole tablet
POS tablet 300 mg taken orally
Other Names:
  • MK-5592
  • SCH 056592
  • Noxafil®




Primary Outcome Measures :
  1. Participants with Treatment Related Adverse Events (AEs) [ Time Frame: Up to 14 days after treatment (up to Day 100) ]
    Percentage of participants who experience one or more treatment-related adverse events (AEs)


Secondary Outcome Measures :
  1. Participants with a favorable global clinical response [ Time Frame: Up to End of Trial (EOT) visit (up to Day 87) ]
    Percentage of participants who have a favorable global clinical response

  2. Participants who have a relapse of invasive aspergillosis (IA) [ Time Frame: Up to 28 days post-treatment (up to Day 114) ]
    Percentage of participants who have a relapse of invasive aspergillosis (IA) at any point after achieving favorable global clinical response

  3. Average plasma concentration (Cavg) of Posaconazole (POS) [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]
    Average plasma concentration (Cavg) of Posaconazole (POS)

  4. Minimum plasma concentration (Cmin) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]
    Minimum plasma concentration (Cmin) of POS

  5. Maximum plasma concentration (Cmax) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]
    Maximum plasma concentration (Cmax) of POS

  6. Area under the concentration-time curve (AUC) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]
    Area under the concentration-time curve (AUC) of POS

  7. Time to reach Cmax (Tmax) of POS [ Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 ]
    Time to reach Cmax (Tmax) of POS

  8. Participants with different categories of palatability [ Time Frame: Day 8 and Day 84 ]
    Percentage of participants with different categories of palatability after treatment with the POS PFS formulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis of possible, probable, or proven IA per modified 2008 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) disease definitions
  • Has one or more of pre-defined risks as per modified 2008 EORTC/MSG disease definitions
  • Meets pre-defined mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions
  • Has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of disease tissue as per modified EORTC/MSG disease definitions
  • Has a central line (e.g., central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning IV study treatment.
  • Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of <30 days.
  • During the intervention period and for at least 30 days after the last dose of study treatment, males agree to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
  • Female is is not pregnant or breastfeeding, and is not a woman of child bearing potential (WOCBP) or is a WOCBP using a highly effective contraceptive method. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.

Exclusion Criteria:

  • Has chronic (≥30 days' duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment.
  • Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used.
  • Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of time of first dose of study treatment.
  • Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Is on artificial ventilation or receiving acute continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BPAP) at the time of first dose of study treatment.
  • Has known or suspected Gilbert's disease.
  • Has received any treatment prohibited by the protocol.
  • Has enrolled previously in the current study and been discontinued.
  • Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218851


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04218851    
Other Study ID Numbers: 5592-104
2019-002267-10 ( EudraCT Number )
MK-5592-104 ( Other Identifier: Merck )
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspergillosis
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs