UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027218 |
|---|---|
| Receipt number | 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 23:30:05 |
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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
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
iida.hiroatsu.kr@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030669
