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Trial record 4 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants

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ClinicalTrials.gov Identifier: NCT03816176
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE January 23, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 240 days ]
    An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
  • Number of participants with vital sign abnormalities and /or adverse events [ Time Frame: Up to 84 days ]
    Number of participants with potentially clinically significant vital sign values
  • Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to 84 days ]
    A 12-lead, resting ECG will be recorded after participant has remained supine for at least 5 minutes. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded
  • Number of participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to 84 days ]
    Number of participants with potentially clinically significant laboratory values
  • All-cause mortality through Day 42 [ Time Frame: Up to 42 days ]
    Each participant will be classified as either a death or alive
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03816176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • All-cause mortality through Day 84 [ Time Frame: Up to 84 days ]
    Each participant will be classified as either a death or alive
  • All-cause mortality at End of Treatment (EOT) [ Time Frame: Up to 180 days ]
    Each participant will be classified as either a death or alive
  • Overall response through Day 42 [ Time Frame: Up to 42 days ]
    Overall response through day 42 will be based on clinical, mycological, and radiological response
  • Overall response through Day 84 [ Time Frame: Up to 84 days ]
    Overall response through day 84 will be based on clinical, mycological, and radiological response
  • Overall response at EOT [ Time Frame: Up to 180 days ]
    Overall response through EOT will be based on clinical, mycological, and radiological response
  • Clinical response through Day 42 [ Time Frame: Up to 42 days ]
    Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
  • Clinical response through Day 84 [ Time Frame: Up to 84 days ]
    Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
  • Clinical response at EOT [ Time Frame: Up to 180 days ]
    Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
  • Radiological response through Day 42 [ Time Frame: Up to 42 days ]
    Each participant will be assessed for radiological evidence of fungal disease
  • Radiological response through Day 84 [ Time Frame: Up to 84 days ]
    Each participant will be assessed for radiological evidence of fungal disease
  • Radiological response at EOT [ Time Frame: Up to 180 days ]
    Each participant will be assessed for radiological evidence of fungal disease
  • Mycological response through Day 42 [ Time Frame: Up to 42 days ]
    Each participant will be assessed for mycological evidence of fungal disease
  • Mycological response through Day 84 [ Time Frame: Up to 84 days ]
    Each participant will be assessed for mycological evidence of fungal disease
  • Mycological response at EOT [ Time Frame: Up to 180 days ]
    Each participant will be assessed for mycological evidence of fungal disease
  • Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough) [ Time Frame: Up to 84 days ]
    Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Official Title  ICMJE A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
Detailed Description

Treatment will begin on Day 1 and then participants will be followed for 60 days post-last dose for safety. Treatment will be administered until the participant has a successful outcome or for a maximum duration of 84 days (IA) or 180 days (IM), whichever occurs first.

All participants will receive a loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (± 2 hours) on Days 1 and 2 (for a total of 6 doses), followed by once daily maintenance dosing for up to 84 days (IA) or 180 days (IM) of dosing. The first maintenance dose should start 12 to 24 hours after the administration of the last loading dose. Subsequent maintenance doses will be administered once daily (24 hours ± 2 hours from the previous maintenance dose).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Invasive Mucormycosis
  • Invasive Aspergillosis
Intervention  ICMJE Drug: Isavuconazonium sulfate
Intravenous (IV) infusion
Other Name: Cresemba
Study Arms  ICMJE Experimental: Isavuconazonium sulfate
All participants will receive a loading dose of isavuconazonium sulfate every 8 hours (± 2 hours) on Days 1 and 2 followed by once-daily maintenance dosing
Intervention: Drug: Isavuconazonium sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject diagnosed with IA or IM. A positive diagnosis is defined as follows:

    • Proven, probable or possible IFI per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria Note: Subjects with "possible" IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as "probable" or "proven" according to the EORTC/MSG criteria must be completed within 7 days after the first dose of study drug
    • Note: In addition to the criteria set for mycological criteria by the EORTC/MSG in 2008, and only for subjects with an underlying hematologic malignancy or recipients of hematopoietic stem cell transplant (HSCT) who also have clinical and radiologic features consistent with invasive fungal infection, the following are acceptable:
    • Galactomannan (GM) levels (optical density index) meeting the below criteria are acceptable mycological evidence for enrollment or upgrading the diagnosis to probable IA:
    • 1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or
    • 2. Two serum GM values of ≥ 0.5 from two separate samples
  • Subject has sufficient venous access to permit administration of study drug and monitoring of safety laboratories
  • A female subject is eligible to participate if not pregnant and at least one of the following conditions applies:

    • Not a subject who is of childbearing potential, OR
    • Subject who is of childbearing potential who agrees to follow a contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration
  • Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment with the exception of oncology trials

Exclusion Criteria:

  • Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal ECG
  • Subject has evidence of hepatic dysfunction defined as any of the following:

    • Total bilirubin (TBL) ≥ 3 times the upper limit of normal (ULN)
    • Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the ULN
    • Known cirrhosis or chronic hepatic failure
  • Subject has used strong cytochrome P450 (CYP3A4) inhibitors or inducers such as ketoconazole, high dose ritonavir, rifampin/rifampicin, long acting barbiturates (e.g., phenytoin), carbamazepine and St. John's Wort in the 5 days prior to the first dose of study drug
  • Subject has another IFI other than possible, probably or proven IA or IM
  • Subject has chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis
  • Subject has received mould active systemic antifungal therapy, effective against the primary IMI, for more than four days during the seven days preceding the first dose

    • Note: Prior use of prophylactic antifungal therapy is acceptable. In case of breakthrough IA while on prophylatic mould-active azole class drugs, additional documentation will be required to be submitted to the sponsor medical monitor or designee to approve subject enrollment
  • Subject has known history of allergy, hypersensitivity or any serious reaction to any of the azole class antifungals
  • Subject has any condition which makes the subject unsuitable for study participation
  • Subject is unlikely to survive 30 days
  • Subject has received investigational drug, with the exception of oncology drug trials, or trials with investigational drugs treating graft versus host disease, within 28 days or five half-lives, whichever is longer, prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Astellas Pharma Global Development 800-888-7704 astellas.registration@astellas.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03816176
Other Study ID Numbers  ICMJE 9766-CL-0107
2018-003975-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Executive Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP