UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006265 |
|---|---|
| Receipt number | 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 16:52:33 |
* 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
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
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
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
0332730905
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 Drug use surveillance
Address
Not applicable for Drug use surveillance
Tel
Not applicable for Drug use surveillance
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007396
