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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008052
Receipt No. 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

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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
Email 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
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009484

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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