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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029434
Receipt No. 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

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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
Email 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
Email kaidak@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Department of hematology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033617

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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