UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001744 |
|---|---|
| Receipt number | 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 14:12:01 |
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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
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
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka Prefectural General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002103
