UMIN-CTR Clinical Trial

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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