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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003775
Receipt No. R000004569
Scientific Title Adding of sitagliptin phosphate hydrate to combination therapy with pegylated interferon alpha 2b and ribavirin for patients with chronic hepatitis C and diabetes mellitus
Date of disclosure of the study information 2010/06/21
Last modified on 2014/11/06

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Basic information
Public title Adding of sitagliptin phosphate hydrate to combination therapy with pegylated interferon alpha 2b and ribavirin for patients with chronic hepatitis C and diabetes mellitus
Acronym ASPIRIN trial
Scientific Title Adding of sitagliptin phosphate hydrate to combination therapy with pegylated interferon alpha 2b and ribavirin for patients with chronic hepatitis C and diabetes mellitus
Scientific Title:Acronym ASPIRIN trial
Region
Japan

Condition
Condition Patients with chronic hepatitis C and hyperglycemia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation the safety and efficacy of sitagliptin phosphate hydrate in patients treated with pegylated interferon and ribavirin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Sustained viral response of HCV
Key secondary outcomes Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sitagliptin phosphate hydrate
pegylated interferon alpha 2b
ribavirin
Interventions/Control_2 pegylated interferon alpha 2b
ribavirin
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
75 years-old >=
Gender Male and Female
Key inclusion criteria chronic hepatitis C
HCV serotype 1
HCV viral load; over 5 log copies/mL
Fasting blood sugar: over 105 mg/dL
Key exclusion criteria pregnant woman
drug allergy
insulin medication
depression
autoimmune diseases
malignant diseases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Tamori
Organization Osaka City University Medical School
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Medical School
Division name Department of Hepatology
Zip code
Address
TEL 06-6645-3811
Homepage URL
Email

Sponsor
Institute Department of Hepatology, Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
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
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 大阪市立大学医学部附属病院、大阪市立総合医療センター、大阪市立十三市民病院

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 21 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 Enrolled patients were few. Now, new anti-HCV drugs were available for patients with chronic hepatitis C. We decide the discontinuation of the present study.
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
2010 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 17 Day
Last modified on
2014 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004569

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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