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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001744
Receipt No. R000002103
Scientific Title A pilot study of interferon alpha suppository treatment for chronic hepatitis C
Date of disclosure of the study information 2009/03/21
Last modified on 2009/03/01

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Basic information
Public title A pilot study of interferon alpha suppository treatment for chronic hepatitis C
Acronym Interferon alpha suppository treatment for chronic hepatitis C
Scientific Title A pilot study of interferon alpha suppository treatment for chronic hepatitis C
Scientific Title:Acronym Interferon alpha suppository treatment for chronic hepatitis C
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of interferon suppository treatment for chronic hepatitis C
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Antiviral effect (decline of the viral load)
Key secondary outcomes (1)Improvement of liver function
(2)Adverse effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lymphoblastoid interferon (1000IU) containing suppository
Interventions/Control_2 Suppository matrix
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
19 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Positive for HCV RNA
Key exclusion criteria Previous or present treatment with interferon, average daily intake of alcohol exceeding 50g of ethanol, choledocholithiasis, cirrhosis, autoimmune hepatitis, primary biliary cirrhosis, hepatitis B virus infection, human immunodeficiency virus infection, drug abuser, drug-related liver disease and pregnancy
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimichi Haruna
Organization Osaka Prefectural General Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-1-56 Bandaihigashi, Sumiyoshiku, Osaka 558-8558, Japan
TEL 06-6692-1201
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimichi Haruna
Organization Osaka Prefectural General Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Email apple-123-grape@ab.auone-net.jp

Sponsor
Institute Osaka Prefectural General Medical Center
Institute
Department

Funding Source
Organization Osaka Prefectural General Medical Center
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 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
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 Completed
Date of protocol fixation
1998 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
1998 Year 10 Month 01 Day
Last follow-up date
2004 Year 10 Month 01 Day
Date of closure to data entry
2004 Year 11 Month 01 Day
Date trial data considered complete
2004 Year 12 Month 01 Day
Date analysis concluded
2005 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 01 Day
Last modified on
2009 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002103

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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