UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003775 |
|---|---|
| Receipt number | 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 09:28:10 |
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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
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
Sponsor or person
Institute
Department of Hepatology, Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004569
| 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 |
