UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of cidofovir for adenovirus infection
Title of the study (Brief title)	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	Masayuki Hino
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology
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	Mika Nakamae
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology(Clinical research center for hematological malignancies )
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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