UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007666 |
|---|---|
| Receipt number | 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 19:41:15 |
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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
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
redasthma@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009034
