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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007666
Receipt No. R000009034
Scientific Title Early therapy with lyposomal amphotericin B (L-AMB) for chronic pulmonary aspergillosis
Date of disclosure of the study information 2012/04/06
Last modified on 2013/10/04

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Basic information
Public title Early therapy with lyposomal amphotericin B (L-AMB) for chronic pulmonary aspergillosis
Acronym Lyposomal amphotericin B for chronic pulmonary aspergillosis
Scientific Title Early therapy with lyposomal amphotericin B (L-AMB) for chronic pulmonary aspergillosis
Scientific Title:Acronym Lyposomal amphotericin B for chronic pulmonary aspergillosis
Region
Japan

Condition
Condition Chronic pulmonary aspergillosis
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy of L-AMB
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical and radiological response at three months after the end of treatment.
Key secondary outcomes Clinical and radiological response at the end of treatment.
Clinical and radiological response at six months after the end of treatment.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 L-AMB is given intravenously at 3.0mg/kg every 24h for 2 to 4 weeks.
Interventions/Control_2 No treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who had been given a diagnosis of chronic pulmonary aspergillosis
2.Ability and willingness to provide informed consent
Key exclusion criteria 1.Patients who received L-AMB within one month before the time of enrollment
2.Patients who newly started antifungal agents within three month before the time of enrollment
3.Patients with simple aspergilloma, invasive pulmonary aspergillosis, or allergic bronchopulmonary aspergollosis
4.Pregnant patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, 431-3192
TEL 053-435-2111
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Akamatsu
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, 431-3192
TEL 053-435-2111
Homepage URL
Email redasthma@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of Medicine
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 浜松医科大学(静岡県)、磐田市立総合病院(静岡県)、天竜病院(静岡県)、浜松労災病院(静岡県)、浜松日赤病院(静岡県)、聖隷三方原病院(静岡県)、遠州病院(静岡県)、島田市民病院(静岡県)、静岡市立静岡病院(静岡県)、静岡市立清水病院(静岡県)、静岡県立総合病院(静岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 04 Day
Last modified on
2013 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009034

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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