UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008045
Receipt No. 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 (Ver. 8)

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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
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 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo
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 Special Drug use surveillance
Address Not applicable for Special Drug use surveillance
Tel Not applicable for Special Drug use surveillance
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009475