UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003709 |
|---|---|
| Receipt number | 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 09:21:09 |
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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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004489
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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