UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008045 |
|---|---|
| Receipt number | R000009475 |
| Scientific Title | Prospective observational study on efficacy and safety of PEGASYS for the treatment of patients with HBeAg positive or HBeAg negative chronic active hepatitis B |
| Date of disclosure of the study information | 2012/05/29 |
| Last modified on | 2019/09/19 09:23:29 |
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Basic information
Public title
Prospective observational study on efficacy and safety of PEGASYS for the treatment of patients with HBeAg positive or HBeAg negative chronic active hepatitis B
Acronym
Prospective observational study of PEGASYS for hepatitis B
Scientific Title
Prospective observational study on efficacy and safety of PEGASYS for the treatment of patients with HBeAg positive or HBeAg negative chronic active hepatitis B
Scientific Title:Acronym
Prospective observational study of PEGASYS for hepatitis B
Region
| Japan |
Condition
Condition
Chronic active hepatitis B (CHB)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
confirmation of efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
virological and biochemical efficacy at 24 weeks (6 months) after treatment
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
patients with HBeAg positive or HBeAg negative chronic active hepatitis B
Key exclusion criteria
chronic active hepatitis B patients without HBeAg data
Target sample size
400
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
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
2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo
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 Special Drug use surveillance
Address
Not applicable for Special Drug use surveillance
Tel
Not applicable for Special Drug use surveillance
Not applicable for special 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
| 2012 | Year | 05 | Month | 29 | 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
536
Results
The incidence of ADRs in the 536 patients in the safety analysis set was 47.76% (256/536 patients), with 565 events reported.
By system organ class (SOC), the most common ADRs (5% incidence) in the 536 patients in the safety analysis set were investigations (28.92%, 155/536 patients), general disorders and administration site condition (12.31%, 66/536 patients), and skin and subcutaneous tissue disorders (9.33%, 50/536 patients.
Results date posted
| 2019 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 555 patients whose case report forms were collected, 3 patients were unevaluable for AEs, 3 patients were found to have breached contract, and 13 patients had enrollment violations; the remaining 536 patients (including 299 HBe antigen-positive patients and 188 HBe antigen-negative patients) constituted the safety analysis set.
Participant flow
Of the 555 patients whose case report forms were collected, 3 patients were unevaluable for AEs, 3 patients were found to have breached contract, and 13 patients had enrollment violations; the remaining 536 patients (including 299 HBe antigen-positive patients and 188 HBe antigen-negative patients) constituted the safety analysis set.
Adverse events
The most common ADRs (5% incidence) were neutrophil count decreased (13.62%, 73/536 patients), platelet count decreased (12.13%, 65/536 patients), pyrexia (9.51% (51/536 patients), and white blood cell count decreased (9.33% (50/536 patients).
Outcome measures
All-patient special drug use surveillance was initiated at contracted institutions on November 1, 2011 with a target sample size of 400 patients in the population of patients receiving Pegasys for improvement of viraemia in HBe antigen-positive or HBe antigen-negative chronic active hepatitis B in order to elucidate the occurrence of ADRs and treatment response in the actual clinical setting as well as to elucidate factors affecting safety and efficacy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 16 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 16 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 11 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | 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=R000009475
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