UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024750 |
|---|---|
| Receipt number | R000028453 |
| Scientific Title | Studies of efficacy and safety of simultaneous administration of febuxostat and inosine for patients with genetic anemia, and changes of blood and urine purine compounds |
| Date of disclosure of the study information | 2017/02/27 |
| Last modified on | 2017/05/09 13:24:06 |
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Basic information
Public title
Studies of efficacy and safety of simultaneous administration of febuxostat and inosine for patients with genetic anemia, and changes of blood and urine purine compounds
Acronym
Effect of febuxostat and inosine on anemia
Scientific Title
Studies of efficacy and safety of simultaneous administration of febuxostat and inosine for patients with genetic anemia, and changes of blood and urine purine compounds
Scientific Title:Acronym
Effect of febuxostat and inosine on anemia
Region
| Japan |
Condition
Condition
genetic anemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of simultaneous administration of febuxostat and inosine on genetic anemia, and changes of blood and urine purine compounds.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of serum haptoglobin between before and after the treatment
Key secondary outcomes
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
Treatment with febuxostat 20 mg and inosine 0.5 g twice a day for 14 days
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
1. Japanese with 20 to 80 years of age
2. Patients diagnosed as purine metabolism abnormalities, hemoglobinopathies, or red blood cell membrane abnormalities such as stomatocytosis with hemolytic anemia including adenylate kinase deficiency or red cell adenosine deaminase overproduction or genetic enzyme deficiencies in glycolysis system such as pyruvate kinase deficiency, glucose phosphate isomerase deficiency, phosphofructokinase deficiency and phosphoglycerate kinase deficiency.
3. Patients with hemoglobin concentration of 10.0 mg/dL or lower as determined within 2 months before the first day of the drug administration.
4. Patients with lower haptoglobin concentration than the normal range as determined within 2 months before the first day of the drug administration.
Key exclusion criteria
1. Subjects taking azathioprine or mercaptopurine
2. Subject who has or had renal function disorder.
3. Subject with a history of gout, hyperuricemia or urolithiasis.
4. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
5. Subjects to whom either transfusion or surgical treatment such as splenectomy was made within 3 months before the initiation of the drug therapy.
6. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Kamatani |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Doctors' office
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
kamatani@msb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Suzuki |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Division for Volunteers
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
Homepage URL
m-suzuki@tsukuba-icp.jp
Sponsor or person
Institute
Tsukuba International Clinical Pharmacology Clinic
Institute
Department
Personal name
Funding Source
Organization
StaGen Co. LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 02 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 10 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028453
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
