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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023490
Receipt No. 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

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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
Email 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
Email fujiwara-to@apple.email.ne.jp

Sponsor
Institute Department of Hematolgy and Rheumatology, Tohoku University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027057

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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