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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003709
Receipt No. R000004489
Scientific Title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for non-responder/relapser to pegylated interferon or non pegylated interferon plus ribavirin
Date of disclosure of the study information 2010/06/05
Last modified on 2019/09/19

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Basic information
Public title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for non-responder/relapser to pegylated interferon or non pegylated interferon plus ribavirin
Acronym PEGASYS/COPEGUS Re-treatment
Scientific Title Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for non-responder/relapser to pegylated interferon or non pegylated interferon plus ribavirin
Scientific Title:Acronym PEGASYS/COPEGUS Re-treatment
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm efficacy and safety of PEGASYS/COPEGUS for re-treatment of patients with chronic hepatitis C.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Sustained virological response (SVR) rate and confirmation of the safety profile including greater than 48wks treatment period
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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who received treatment with IFN (including PEG IFN) plus RBV and did not reach sustained virological response (SVR).
Key exclusion criteria 1. Despite of administering adequate doses of PEG IFN plus RBV for 48weeks, HCV RNA did not become negative by 36weeks
2. Patients who have had treatment of PEG IFN plus RBV for 72weeks
3. Coadministration of Shosaikoto
4. History of interstitial pneumonia
5. Autoimmune hepatitis
6. Hypersensitivity to PEG IFN or RBV or to any of the excipients or biological products or nucleotide analogs
7. Low birth weight baby, neonate, infant or children under age 3
8. Pregnancy, uncertainty pregnancy or brest feeding women
9. Uncontrolled cardiac disease
10. Hemoblobinopathies (e.g. thalassemia, sickle cell anemia)
11. Chronic renal failure or CCl<50mL/min of renal dysfunction
12. Histry or presence of severe depression, severe neuropsychiatric disorder with suicidal ideation or suicide attempt
13.Severe hepatic dysfunction
Target sample size 1000

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 103-8324 Japan
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 shimizuayk@chugai-pharm.co.jp
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 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
2010 Year 06 Month 05 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 851
Results The SVR rate was higher in the patients receiving 48 weeks of treatment (long-term treatment patients) in the 516-patient serotype 1 group of the effectiveness analysis set.
The SVR rate was similar in the patients receiving 48 weeks of treatment (long-term treatment patients) and the patients receiving 48 weeks of treatment in the 206-patient serotype 2 group of the effectiveness analysis set.


Results date posted
2019 Year 04 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics patients with chronic hepatitis C receiving retreatment with Pegasys plus Copegus after previous treatment with interferon plus ribavirin.
Participant flow In the current surveillance study in treatment-experienced patients, 929 case report forms were collected from 948 enrolled patients. This excluded 19 patients without completed case report forms. The safety analysis set included 851 of the 929 patients with completed case report forms. This excluded 78 patients who were excluded from the safety analysis. The effectiveness analysis set included 736 of the 851 patients in the safety analysis set. This excluded 115 patients who were excluded from the effectiveness analysis.
Adverse events Treatment of 48 weeks was received by 398 of the 851 patients in the safety analysis set. A comparison with the 446 patients who received 48 weeks of treatment revealed that the incidence of ADRs was higher in patients who received 48 weeks of treatment (77.38%) than patients who received 48 weeks of treatment (70.62%). Decreased hemoglobin was the only ADR occurring with a 5% higher incidence in patients with 48 weeks of treatment than patients with 48 weeks of treatment.
Outcome measures In the current surveillance study in treatment-experienced patients, 929 case report forms were collected from 948 enrolled patients. This excluded 19 patients without completed case report forms. The safety analysis set included 851 of the 929 patients with completed case report forms. This excluded 78 patients who were excluded from the safety analysis.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 04 Month 16 Day
Date of IRB
2010 Year 04 Month 16 Day
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information 1. Demographics
2. Information of administration of PEGASYS and COPEGUS
3. Efficacy: HCV RNA assessed by Real-time PCR
4. Safety: Adverse events

Management information
Registered date
2010 Year 06 Month 04 Day
Last modified on
2019 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004489

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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