UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008052 |
|---|---|
| Receipt number | R000009484 |
| Scientific Title | Follow up study on LC of PEGASYS/COPEGUS in Phase II/III |
| Date of disclosure of the study information | 2012/05/29 |
| Last modified on | 2019/04/05 16:52:58 |
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Basic information
Public title
Follow up study on LC of PEGASYS/COPEGUS in Phase II/III
Acronym
Follow up study on LC of PEGASYS/COPEGUS in Phase II/III
Scientific Title
Follow up study on LC of PEGASYS/COPEGUS in Phase II/III
Scientific Title:Acronym
Follow up study on LC of PEGASYS/COPEGUS in Phase II/III
Region
| Japan |
Condition
Condition
Chronic hepatitis C with compensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm developing HCC rate and advance of decompensatory cirrhosis rate of SVR and NonSVR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
developing HCC rate and advance of decompensatory cirrhosis rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were included in Phase II/III (JV19595 and JV19889) are able to follow up
Key exclusion criteria
-
Target sample size
149
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kawashima |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Real World Data Science Dept.
Zip code
103-8324
Address
2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo
TEL
03-3273-0769
kawashimaizm@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Shimizu |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Real World Data Science Dept.
Zip code
103-8324
Address
2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo
TEL
03-3273-0905
Homepage URL
shimizuayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai 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
Not applicable for Special Drug use surveillance
Address
Not applicable for Special Drug use surveillance
Tel
Not applicable for Special Drug use surveillance
Not applicable for special Drug use surveillance
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
| 2012 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Not opened
Publication of results
Unpublished
Result
URL related to results and publications
Not opened
Number of participants that the trial has enrolled
145
Results
The median (minimum to maximum) duration of observation was 5.88 (0.18 to 7.72) years. Progression to decompensated cirrhosis was observed in 11 of the 139 patients.
In patient years (100 patient years), the overall incidence of progression to decompensation was 1.49. By virological response (SVR, VR, NR), the incidence was 0.00, 0.34, and 4.18, respectively.
Results date posted
| 2019 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Progression to decompensated cirrhosis was evaluated in 139 of the 145 patients in the analysis set. This excluded 6 patients with unknown status of progression to decompensated cirrhosis.
Participant flow
The analysis set included 145 patients, with no patients excluded from analysis.
Progression to decompensated cirrhosis was evaluated in 139 of the 145 patients in the analysis set. This excluded 6 patients with unknown status of progression to decompensated cirrhosis.
Adverse events
Because the objective of this surveillance study was to examine the post-treatment clinical course (incidence of liver [hepatocellular] cancer and progression to decompensated cirrhosis) of patients who had received treatment with Pegasys plus Copegus, data on safety were not collected.
Outcome measures
Because the objective of this surveillance study was to examine the post-treatment clinical course (incidence of liver [hepatocellular] cancer and progression to decompensated cirrhosis) of patients who had received treatment with Pegasys plus Copegus, data on safety were not collected.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009484
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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