UMIN-CTR Clinical Trial

Basic information
Public title	An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.
Acronym	An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.
Scientific Title	An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym	An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.
Region	Japan

Condition
Condition	Invasive fungal infection
Classification by specialty	Hematology and clinical oncology Infectious disease
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of prophylactic administration of voriconazole in allogeneic hematopoietic stem cells transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of proven/probable invasive aspergillosis until one year after transplantation.
Key secondary outcomes	Continuation rate of voriconazole administration at day+100 after transplantation. Adverse event due to voriconazole administration. Incidence rate of proven invasive fungal infection other than invasive aspergillosis during voriconazole administration. Relationship between blood concentration of voriconazole and incidence rate of proven/probable invasive fungal infection. Effect of voriconazole administration on blood concentration of a calcineurin inhibitor.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Oral administration of voriconazole is started seven days before the transplantation day, at least for 100 days after the transplantation until neutrophils reach 500/micro L or more and immunosuppressant is discontinued. Dosage and administration: for patients with a body weight of 40 kg or more, 300 mg of voriconazole twice a day on the first day followed by 200 mg of voriconazole twice a day between meals after the second day are administered orally. For patients with a body weight of less than 40 kg, 150 mg of voriconazole twice a day on the first day followed by 100 mg of voriconazole twice a day between meals after the second day are administered orally.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who are scheduled to undergo the first allogeneic hematopoietic stem cell transplantation at Nagoya Medical Center in the period from March 1, 2017 to February 28, 2019. 2)Patients who provided written consents for this study by themselves. 3)Patients aged 20 years or older at the time of acquisition of informed consent. 4)Patients who have not received voriconazole at the time of consent acquisition, or patients without proven/probable invasive fungal infection who are administered with voriconazole. 5)Patients with performance status (ECOG) of grade 0-3.
Key exclusion criteria	1)Patients with proven/probable invasive fungal infection at the time of acquisition of informed consent (patients can be registered if cure is confirmed at the time of participation in the study and an antifungal drug is not used for therapeutic purpose). 2)Patients with a history of hypersensitivity to the components of voriconazole. 3)Patients with creatinine clearance less than 30 ml/min at the time of participation in the study. 4)Patients with grade C by Child-Pugh classification. 5)Patients with a complication of cardiac disease (including arrhythmia) which requires treatment. 6)Patients with a mental disorder, a psychiatric symptom, or cognitive impairment. 7)Patients who are pregnant, possibly pregnant, or breastfeed. 8)Patients who are taking or scheduled to be administered a prohibited drug concomitantly with voriconazole. 9)Patients under HIV treatment. 10)Patients for whom the principal investigator or other investigators decided not suitable for participation in this study.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Hiroatsu Middle name Last name Iida
Organization	National Hospital Organization Nagoya Medical Center
Division name	Hematology
Zip code	460-0001
Address	4-1-1, Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Email	iida.hiroatsu.kr@mail.hosp.go.jp

Public contact
1st name of contact person	1st name Hiroatsu Middle name Last name Iida
Organization	National Hospital Organization Nagoya Medical Center
Division name	Hematology
Zip code	460-0001
Address	4-1-1, Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	iida.hiroatsu.kr@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Nagoya Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Nagoya Medical Center
Address	4-1-1, Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
Tel	052-951-1111
Email	rec@nnh.hosp.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	独立行政法人　国立病院機構 名古屋医療センター

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 15 Day
Date of IRB	2017 Year 05 Month 07 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date	2020 Year 05 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 02 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030669