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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027218
Receipt No. R000030669
Scientific Title An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2017/05/08
Last modified on 2019/05/13

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000030669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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