UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004336 |
|---|---|
| Receipt number | R000004967 |
| Scientific Title | Safety and efficacy of cidofovir for adenovirus infection |
| Date of disclosure of the study information | 2010/10/06 |
| Last modified on | 2018/09/21 23:01:26 |
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Basic information
Public title
Safety and efficacy of cidofovir for adenovirus infection
Acronym
Safety and efficacy of cidofovir for adenovirus infection
Scientific Title
Safety and efficacy of cidofovir for adenovirus infection
Scientific Title:Acronym
Safety and efficacy of cidofovir for adenovirus infection
Region
| Japan |
Condition
Condition
adenovirus infection
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will prospectively examine safety and efficacy of a medium-dose cidofovir (CDV) 3mg/kg/day once a week for adenovirus infection after allogeneic hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disappearance of signs and symptoms in association with adenovirus infection
Elimination of adenovirus from the tissue specimen on which diagnosis of adenovirus infection was made.
Key secondary outcomes
Reduction of viral load
Improvement of clinical symptoms, imaging findings and abnormal laboratory values in association with adenovirus infection.
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
The induction therapy consists of CDV 3 mg/kg/day infused intravenously for 1 hr once a week for the first 3 weeks. The same dose is administered once every 2 weeks after the induction therapy as maintenance therapy.
Intravenous hydration with normal saline is required just before CDV administration as supportive treatment.Additionally, probenecid 2g is orally given 3 hours before and probenecid 1g is given 2 and 8 hours after CDV administration.
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
Patients who had received allogeneic hematopoietic stem cell transplantation (using bone marrow, peripheral blood or cord blood as stem cell source)must be fulfilled at least one of the following.
1) Patients who were diagnosed as adenovirus infection refractory to conservative treatment
2) Patients with adenoviremia who have clinical manifestation
Key exclusion criteria
Subjects who meet any of the following criteria are not eligible.
1) Positive for anti-HIV antibody
2) Positive for hepatitis B surface antigen or HBV-DNA
3) Positive for anti-HCV antibody
4) Creatinine clearance lower than 0.1ml/min/kg calculated by the Cockcroft-Gault formula
5) Patients who have coexisting sinusoidal obstruction syndrome
6) Known hypersensitivity to cidofovir
7) Known hypersensitivity to probenecid
8) Patients who are ineligible for this study as judged by the investigator
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hino |
Organization
Osaka City University, Graduate School of Medicine
Division name
Hematology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
hinom@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Nakamae |
Organization
Osaka City University, Graduate School of Medicine
Division name
Hematology(Clinical research center for hematological malignancies )
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
Homepage URL
crc-hematology@med.osaka-cu.ac.jp
Sponsor or person
Institute
Hematology, Osaka City University, Graduate School of Meicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 10 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004967
