UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029434 |
|---|---|
| Receipt number | R000033617 |
| Scientific Title | single center non-randomized clinical trial of efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2019/04/16 16:09:36 |
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Basic information
Public title
single center non-randomized clinical trial of efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Acronym
a clinical trial of efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Scientific Title
single center non-randomized clinical trial of efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Scientific Title:Acronym
a clinical trial of efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
adenovirus infection after hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively examines efficacy and safety of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
virological response after treatment
Key secondary outcomes
1. side effect of cidofovir
2. pharmakokinetics of cidofovir
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cidofovir 1mg/kg/day is administrated intravenously three times a week. Injection week and drug dose is adjusted depending on patient condition. Pharmakokinetics of cidofovir is measured.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who have received hematopoietic stem cell transplantation
2. patients with adenovirus infection
3. patients with risk of adenovirus infection
4. patients who agree in writing
Key exclusion criteria
1. patients with allergy to cifofovir
2. patients who are recognized as inadaptable for this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuji |
| Middle name | |
| Last name | Kaida |
Organization
Hyogo college of medicine
Division name
Department of hematology
Zip code
663-8181
Address
Mukogawacho 1-1, Nishinomiya-city, Japan
TEL
0798-45-6886
kaidak@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsuji |
| Middle name | |
| Last name | Kaida |
Organization
Hyogo college of medicine
Division name
Department of hematology
Zip code
6638181
Address
Mukogawacho 1-1, Nishinomiya-city, Japan
TEL
0798-45-6886
Homepage URL
kaidak@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Department of hematology
Institute
Department
Personal name
Funding Source
Organization
Hyogo college of medicine
Department of hematology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo college of medicine
Address
Mukogawacho 1-1, NIshinomiya-city
Tel
0798456111
hyo-med@esct.bvits.com
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
Hyogo college of medicine hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 05 | 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
3
Results
ADV suppressing effect observed in all 3 cases.
Results date posted
| 2019 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
HSCT patients for hematological malignancy
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033617
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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