UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014234 |
|---|---|
| Receipt number | R000016582 |
| Scientific Title | Post Marketing Study of Stronger Neo Minophagen C for Elderly Patients of Chronic Hepatitis C -Prospective Study- |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2014/06/11 16:07:14 |
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Basic information
Public title
Post Marketing Study of Stronger Neo Minophagen C for Elderly Patients of Chronic Hepatitis C
-Prospective Study-
Acronym
Post Marketing Study of Stronger Neo Minophagen C for Elderly Patients of Chronic Hepatitis C
Scientific Title
Post Marketing Study of Stronger Neo Minophagen C for Elderly Patients of Chronic Hepatitis C
-Prospective Study-
Scientific Title:Acronym
Post Marketing Study of Stronger Neo Minophagen C for Elderly Patients of Chronic Hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Cirrhosis
Hepatoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It thus set out to investigate the efficacy and safety of SNMC for older chronic hepatitis C patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It thus set out to investigate the efficacy and safety of SNMC for 70 years or older chronic hepatitis C patients and therefore generally unable to receive antiviral therapy.
Key secondary outcomes
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
| 70 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis C patients with alanine aminotransferase (ALT) 31IU/L or higher who could not receive antiviral therapy
70 years or older at the time of registration, and intended to undergo treatment for at least one year
Key exclusion criteria
Contraindication(s) for SNMC treatment
Presence of hepatitis B
Being deemed otherwise unsuitable by the physicians conducting the study.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Kawasaki |
Organization
Minophagen Pharmaceutical Co.,Ltd
Division name
Pharmacovigilance Department CRC&QA Division
Zip code
Address
3-2-11, Nishi-Shinjuku Shinjuku-ku, Tokyo
TEL
03-5909-2131
n_kawasaki@minophagen.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunio Okuni |
Organization
Minophagen Pharmaceutical Co.,Ltd
Division name
Medical Information Department
Zip code
Address
3-2-11, Nishi-Shinjuku Shinjuku-ku, Tokyo
TEL
03-5909-0033
Homepage URL
k_ookuni@minophagen.co.jp
Sponsor or person
Institute
Minophagen Pharmaceutical Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Minophagen Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016582
| Research Plan | |
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| 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 |
