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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003957
Receipt No. R000004766
Scientific Title Evaluation of the efficacy of Sitagliptin plus peginterferon alfa 2b /ribavirin combination therapy in CHC patients with insulin resistance
Date of disclosure of the study information 2010/08/01
Last modified on 2010/07/27

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Basic information
Public title Evaluation of the efficacy of Sitagliptin plus peginterferon alfa 2b /ribavirin combination therapy in CHC patients with insulin resistance
Acronym ESPRIT study
Scientific Title Evaluation of the efficacy of Sitagliptin plus peginterferon alfa 2b /ribavirin combination therapy in CHC patients with insulin resistance
Scientific Title:Acronym ESPRIT study
Region
Japan

Condition
Condition Hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of Sitagliptin and PEG/RBV combination therapy on insulin resistance and the antiviral effect
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SVR rate
Key secondary outcomes HOMA-IR decrease
safet

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dietary intervention(3 months before PEG/RIB treatment)
Interventions/Control_2 Dietary intervention(3 months before PEG/RIB treatment) + sitagliptin 50mg Q.D.oral administration) from 3 month before PEG/RIB treatment to end of PEG/RIB treatment)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic hepatitis C
Insulin resistance(HOMA≥2)
HCV viral load≥ 5 log copies/mL
HCV genotype 1
Key exclusion criteria 1) Pregnant , possibly pregnant or lactating women
2) Patients with severe heart diseases
3) Chronic kidney failure or creatinine clearance of <=50 mL/min
4) Current or history of severe psychiatric disorder
5) Autoimmune hepatitis
6) Intolerance to sitagliptin
7) medication for diabetes
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo College Of Medicine
Division name Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Saito
Organization Hyogo College Of Medicine
Division name Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hyogo College Of Medicine
Institute
Department

Funding Source
Organization Hyogo College Of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 27 Day
Last modified on
2010 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004766

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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