UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001031 |
|---|---|
| Receipt number | R000001226 |
| Scientific Title | A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection. |
| Date of disclosure of the study information | 2008/03/31 |
| Last modified on | 2020/08/23 10:34:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection.
Acronym
A prospective cohort study in patients with hepatitis C virus infection.
Scientific Title
A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection.
Scientific Title:Acronym
A prospective cohort study in patients with hepatitis C virus infection.
Region
| Japan |
Condition
Condition
Patients with hepatitis C virus infection.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the natural course and the efficacy and safety of medical intervention in patients with hepatitis C virus infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death (liver related or unrelated).
Key secondary outcomes
1. Development of hepatocellular carcinoma.
2. Progression to hepatic decompensation.
3. Progression to cirrhosis.
4. Achievement of sustained virological response.
5. Achievement of sustained biochemical response.
6. Adverse events, dose modification, and discontinuation of therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients with or with histry of hepatitis C virus infection.
Key exclusion criteria
None
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
yiwasaki@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
yiwasaki@okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2008 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2001 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2005 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2001 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consecutively enrolled, prospective cohort study
Management information
Registered date
| 2008 | Year | 02 | Month | 13 | Day |
Last modified on
| 2020 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001226
