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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008686
Receipt No. R000010207
Scientific Title The Effect of Febuxostat on the Patient with Hyperuricemia and Non-alcoholic Steatohepatitis
Date of disclosure of the study information 2012/08/15
Last modified on 2014/08/16

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Basic information
Public title The Effect of Febuxostat on the Patient with Hyperuricemia and Non-alcoholic Steatohepatitis
Acronym Hyperuricemia and Non-alcoholic Steatohepatitis
Scientific Title The Effect of Febuxostat on the Patient with Hyperuricemia and Non-alcoholic Steatohepatitis
Scientific Title:Acronym Hyperuricemia and Non-alcoholic Steatohepatitis
Region
Japan

Condition
Condition Hyperuricemia and Non-Alcoholic Steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Several epidemiological studies have suggested that hyperuricemia is one of the causes of Non-alcoholic steatohepatitis (NASH) or related to the progression of NASH. However, no prospective studies have been done to test the effect of treatment of hyperuricemia on NASH. Thus, the aim of this study is to test the efficiency and safety of Febuxostat, one of uric acid-lowering agent, on the patient with hyperuricemia and NASH and clarify the role of hypeuricemia on NASH.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Improvement of serum ALT after taking Febuxostat for 6 months
Key secondary outcomes The following are assessed after taking Febuxostat for 6 months;
1. Safety
2. Improvement of fatty liver by CT
3. Improvement of histological findings of liver
4. The effect of Febuxostat on serum uric acid, liver function except for ALT, renal function, lipid and glucose metabolism, cytokines, and oxidative-stress marker.
5. The effect of Febuxostat on the gene expression related to uric metabolism and glucose metabolism in blood and liver

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 Febuxostat 10mg per day will be given to the patients as the first dose, and then it can be increased to 20mg and 40mg per day every 4 week. The maintenance dose should be 40mg per day, however, it can be increased up to 60mg depend on the status of the patients. It should be taken once a day, every morning.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Serum uric acid; more than 7.0 mg/dl
2. Diagnosed as NASH by imaging studies or histological test(The histological test should be done within 5 years before entry of this study.)
3. Serum ALT; greater than or equal to 31 IU/L
4. Tolerable to take Febuxostat for at least 6 months
5. Child-Pugh classification A
6. Age older than or equal to 20 years old at the entry
7. Performance status (ECOG scale) 0 or 1
8. The function of main organs should be well maintained within 30 days before entry.
1. WBC; greater than or equal to 3000 and less than 12000 /ul
2. Hb; greater than or equal to 9.0g/dL
3. Platelet; greater than or equal to 70000 /ul
4. Total Bilirubin; less than or equal to 1.5 mg/dL or lower than upper limit of the clinic
5. Serum Cr; less than or equal to1.5 mg/dL
6. Serum ALT; greater than or equal to 31 and less than 200 U/L
9. The patients have to agree to join this study by their free wills after being well explained about this study.
10. Outpatient
Key exclusion criteria The following patients should be excluded;
1. Infected with HBV or HCV
2. Alcohol assumption per day; greater than or equal to 30g for male, 20g/day for female
3. Accompanied with obvious malignant diseases including hepatoma
4. Accompanied with obvious hepatic encephalopathy
5. Accompanied with active infectious diseases (body temperature; higher or equal to 38 degree)
6.Accompanied with severe complications such as paralysis of intestine, ileus, interstitial pneumonia, pulmonary fibrosis, poorly controlled diabetes mellitus, heart failure, renal failure, liver failure, active ulcer and risky varix of digestive tract, and severe mental disturbance or depression etc.
7. Nursing woman and pregnant woman or the woman who may be pregnant
8. Taking contraindicating medicines with Febuxostat, such as mercaptopurine-hydrate, azathioprine, vidarabine, or didanosine.
9. Taking the following medicines which could affect serum uric acid within 4 weeks before considering entry of this study; losartan, fenofibrate, loop diuretic, or thiazide diuretic.
10. Taking the following uric acid-lowering medicines within 4 weeks before considering entry of this study; allopurinol, benzbromarone, probenecid, bucolome, or febuxostat.
11. Taking salicylated medicines everyday, however, the patients taking low dose of aspirin salicylate (less than or equal to 324 mg/day) cannot be excluded.
12.Taking estrogenic hormone everyday.
13. The other patients who the doctors in charge consider should not enter this study.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuguhito Ota
Organization Kanazawa University Hospital
Division name Department of Diabetes, Metabolism, and Endocrinology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2235
Email shimakami@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Shimakami
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2235
Homepage URL
Email shimakami@m-kanazawa.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Disease Control and Homeostasis
Institute
Department

Funding Source
Organization Teijin Pharma
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 5789
Org. issuing International ID_1 Kanazawa University Hospital, Center for Clinical Research Management
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 黒部市民病院(富山県)、富山労災病院(富山県)、厚生連滑川病院(富山県)、富山県立中央病院(富山県)、富山市民病院(富山県)、厚生連高岡病院(富山県)、市立砺波総合病院(富山県)、公立羽咋病院(石川県)、公立能登総合病院(石川県)、金沢医療センター(石川県)、金沢市立病院(石川県)、金沢赤十字病院(石川県)、石川県済生会金沢病院(石川県)、公立松任中央病院(石川県)、能美市立病院(石川県)、小松市民病院(石川県)、恵寿総合病院(石川県)、金沢有松病院(石川県)、やわたメディカルセンター(石川県)、河北中央病院(石川県)、加登病院(石川県)、北國クリニック(石川県)、福井県済生会病院(福井県)、くまがい内科クリニック(福井県)、市立敦賀病院(福井県)、

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 15 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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 15 Day
Last follow-up date
2014 Year 07 Month 31 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 08 Month 14 Day
Last modified on
2014 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010207

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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