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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003185
Receipt No. R000003849
Scientific Title Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
Date of disclosure of the study information 2010/02/15
Last modified on 2016/11/02

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Basic information
Public title Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
Acronym L-AMB for FN.(C-SHOT1001)
Scientific Title Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
Scientific Title:Acronym L-AMB for FN.(C-SHOT1001)
Region
Japan

Condition
Condition Hematological malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To make clear the effectiveness of empirical therapy of L-AMB for febrile neutropenia in patients with haematological malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes *Keeping up body temperature under 38degrees celcius for 48 hours.
*No invasive fungal infection
*No change of antifungal agents
*No interruption of treatment due to adverse reactions
*Patient survival
Key secondary outcomes *Frequencies of adverse reactions
*Alleviation of fever
*The therapy finished.

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 Empirical therapy of L-AMB
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with haematological malignancies accompanied by febrile neutropenia who do not respond to antibiotics.
Age ranging from 16 to 79.
Key exclusion criteria (1) Allergy to L-AMB
(2) Infection with proven pathogens
(3) HIV-antibody positive
(4) Pregnant or lactating patients
(5) Patients after allogeneic stem cell transplantation
(6) Invasive fungal infections
(7) Those considered inappropriate to be participated
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Emi
Organization Fujita Health University
Division name Department of Hematology
Zip code
Address 1-9-8 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL 0562-93-2000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Sawa
Organization Anjo Kosei Hospital
Division name Department hematology and oncology
Zip code
Address 28 Higashihirokute Anjo-cho Anjo Aichi
TEL 0566-75-2111
Homepage URL
Email support@c-shot.or.jp

Sponsor
Institute Center for Supporting Hematology-Oncology Trials
Institute
Department

Funding Source
Organization Center for Supporting Hematology-Oncology Trials
Organization
Division
Category of Funding Organization Non profit foundation
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 02 Month 15 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
2010 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 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 02 Month 15 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003849

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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