UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000006265
Receipt No. R000007396
Scientific Title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
Date of disclosure of the study information 2011/09/01
Last modified on 2019/04/05 (Ver. 9)

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Basic information
Public title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
Acronym Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
Scientific Title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
Scientific Title:Acronym Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
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 the safety profile including greater than 48wks treatment period in real world
To assess the efficacy (primary endpoint: sustained virological response (SVR))
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy: HCV RNA unditectable at 24 weeks after treatment (sustained virological response, SVR)
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 #Diagnosis of CHC with compensated LC by the investigator
#Positive serum HCV RNA
Key exclusion criteria All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered.
The major exclusion criteria are:
#Coadministration of Shosaikoto
#Autoimmune hepatitis
#Severe hepatic dysfunction
#Unstable or uncontrolled cardiac disease
#Hypersensitivity to peginterferon or ribavirin or to any of the excipients
#Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details)
#Breast-feeding women
#Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)
Target sample size 500

Research contact person
Last 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 0332730769
Email kawashimaizm@chugai-pharm.co.jp

Public contact
1st 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 0332730905
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 Drug use surveillance
Address Not applicable for Drug use surveillance
Tel Not applicable for Drug use surveillance
Email Not applicable for 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
2011 Year 09 Month 01 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 487
Results 
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis.
Results date posted
2019 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The 487 patients in the safety analysis set had the following baseline characteristics. The patients were 56.46% (275/487) male and 43.53% (212/487) female.
Participant flow 
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis.
Adverse events 
The incidence of adverse drug reactions (ADRs) in the 487 patients in the safety analysis set was 74.94% (365/487 patients), with 1036 events reported. Although differences in treatment duration, length of observation, and patient baseline characteristics prevent a direct comparison, the incidence of ADRs in the surveillance study was lower than that prior to approval (100.00%, 61/61 patients).
Outcome measures 
The sustained virological response (SVR) rate 24 weeks after treatment completion was 16.66% (30/180) in the 180 patients evaluable for SVR rate from the 200 patients in the serotype 1/high viral load group of the efficacy analysis set. The ALT normalization rate (30 IU/L) 24 weeks after treatment completion was 43.82% (71/162) in the 162 patients evaluable for biological response.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 07 Month 12 Day
Date of IRB
2011 Year 07 Month 12 Day
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2015 Year 07 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess the following efficacy
- SVR, end of treatment response, ALT normalization rate
- Above efficacy variables by HCV genotype and viral load
To confirm advanced liver disease (decompensated LC, development of HCC ) during follow up (by June 2014)
To assess factors influencing efficacy and safety
Identification and confirmation of host-, virus- and treatment-related factors (e.g. age, body weight, gender, pre-treatment viral load, ALT ratio, liver fibrosis stage, on-treatment response and treatment exposure) influencing virological response, SVR and relapse
Correlation between overall treatment duration after HCV RNA becomes negative and SVR by genotype
Correlation of cumulative ribavirin and cumulative peginterferon dose with SVR by genotype.
To confirm frequency of hematological test
To confirm frequency and reason for dose modification

Management information
Registered date
2011 Year 09 Month 01 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=R000007396