UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011158 |
|---|---|
| Receipt number | R000013072 |
| Scientific Title | multicenter non-randomized non-blind exploratory clinical trial of safety and efficacy of cidofovir for adenovirus infection after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2020/01/16 20:34:11 |
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Basic information
Public title
multicenter non-randomized non-blind exploratory clinical trial of safety and efficacy of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Acronym
A clinical trial of administration of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Scientific Title
multicenter non-randomized non-blind exploratory clinical trial of safety and efficacy of cidofovir for adenovirus infection after hematopoietic stem cell transplantation
Scientific Title:Acronym
A clinical trial of administration 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 | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study will prospectively examine safety and efficacy of a low-dose short-term 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) Clinical response of adenovirus infection
2) Adverse events
3) Survival at 2 months after treatment
Changes of data below from pre to post-treatment
4) Serum creatinine
5) Proteinuria, urine occult blood
6) Blood cell count
7) Venous blood gas analysis
8) Number of cytomegalovirus antigen positive cell
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 1 mg/kg/day is administrated intravenously three times a week for two weeks. Intravenous hydration with normal saline and oral probenecid are required to prevent renal damage.
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
| 16 | years-old | <= |
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 to be severe
4. Patients who agree in writing
Key exclusion criteria
1. Allergy to drugs used in this trial
2. Serum creatinine higher than 1.5 mg/dl (In case of renal dysfunction by viral infection, higher than 2.5 mg/dl)
3. History of receiving foscarnet
4. During pregnancy, breastfeeding or potential pregnancy
5. Patients who are recognized as inadaptable for this trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Fujimoto |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Hematology
Zip code
Address
N15 W7, Kita-ku, Sapporo, Japan, 060-8638
TEL
011-706-7214
kfujimo@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Fujimoto |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Hematology
Zip code
Address
N15 W7, Kita-ku, Sapporo, Japan, 060-8638
TEL
011-706-7214
Homepage URL
kfujimo@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
North Japan Hematology Study Group
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013072
