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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004336
Receipt No. 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

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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
Email 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
Email crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute Hematology, Osaka City University, Graduate School of Meicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004967

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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