UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023490 |
|---|---|
| Receipt number | R000027057 |
| Scientific Title | The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2018/08/06 11:00:43 |
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Basic information
Public title
The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia
Acronym
The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia
Scientific Title
The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia
Scientific Title:Acronym
The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia
Region
| Japan |
Condition
Condition
Sideroblastic anemia (congenital and acquired)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the safety and efficacy of 5-aminolevulinic acid (ALA) therapy for congenital and acquired sideroblastic anemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate if ALA responds to the therapy, hemoglobin levels at 12 and 24 weeks will be compared with the data at pre-treatment. Effectiveness is defined as more than 1g/dL increase in hemoglobin level (if the case undergoes regular red blood cell transfusion, the effectiveness is defined as achieving transfusion withdrawal.).
Key secondary outcomes
Onset of adverse event is evaluated at 2 weeks, 4 weeks, and thereafter every 4 weeks up to 12 months. The grade is defined according o the Common Terminology Criteria for Adverse Events (CTCAE) v4 guideline.
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
| Food |
Interventions/Control_1
Food supplement containing 150 mg of ALA phosphate was given per day for 24 weeks. For the evaluation of efficacy and safety, medical examinations as well as urine and blood tests will be performed prior to administration of ALA, then at 2 and 4 weeks, and thereafter every month (up to 12 months).
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with sideroblastic anemia (congenital and acquired), who agreed to participate in the study.
Key exclusion criteria
1) Thrombocytopenia (less than 100,000), neutropenia (less than 1,500)
2)Patients who do not understand the study.
3) Serious complication (renal insufficiency with Ccr < 30 ml/min, liver insufficiency with total bilirubin >2 mg/dL, hypoxia requiring home oxygen therapy)
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harigae Hideo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Hematolgy and Rheumatology
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7165
harigae@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujiwara Tohru |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Hematolgy and Rheumatology
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7165
Homepage URL
fujiwara-to@apple.email.ne.jp
Sponsor or person
Institute
Department of Hematolgy and Rheumatology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | 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
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 20 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027057
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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