UMIN-CTR Clinical Trial

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
Email	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
Email	kfujimo@med.hokudai.ac.jp

Sponsor
Institute	North Japan Hematology Study Group
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013072