UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006265
Receipt number	R000007396
Scientific Title	Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
Date of disclosure of the study information	2011/09/01
Last modified on	2019/04/05 16:52:33

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Basic information

Public title

Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Acronym

Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Scientific Title

Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Scientific Title:Acronym

Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC

Region

Japan

Condition

Chronic hepatitis C with compensated liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To confirm the safety profile including greater than 48wks treatment period in real world
To assess the efficacy (primary endpoint: sustained virological response (SVR))

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Efficacy: HCV RNA unditectable at 24 weeks after treatment (sustained virological response, SVR)

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

#Diagnosis of CHC with compensated LC by the investigator
#Positive serum HCV RNA

Key exclusion criteria

All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered.
The major exclusion criteria are:
#Coadministration of Shosaikoto
#Autoimmune hepatitis
#Severe hepatic dysfunction
#Unstable or uncontrolled cardiac disease
#Hypersensitivity to peginterferon or ribavirin or to any of the excipients
#Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details)
#Breast-feeding women
#Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)

Target sample size

500

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

0332730769

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

0332730905

Homepage URL

Email

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

Email

Not applicable for Drug use surveillance

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 01 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

487

Results

The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis.

Results date posted

2019 Year 04 Month 05 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The 487 patients in the safety analysis set had the following baseline characteristics. The patients were 56.46% (275/487) male and 43.53% (212/487) female.

Participant flow

Adverse events

The incidence of adverse drug reactions (ADRs) in the 487 patients in the safety analysis set was 74.94% (365/487 patients), with 1036 events reported. Although differences in treatment duration, length of observation, and patient baseline characteristics prevent a direct comparison, the incidence of ADRs in the surveillance study was lower than that prior to approval (100.00%, 61/61 patients).

Outcome measures

The sustained virological response (SVR) rate 24 weeks after treatment completion was 16.66% (30/180) in the 180 patients evaluable for SVR rate from the 200 patients in the serotype 1/high viral load group of the efficacy analysis set. The ALT normalization rate (30 IU/L) 24 weeks after treatment completion was 43.82% (71/162) in the 162 patients evaluable for biological response.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 07 Month 12 Day

Date of IRB

2011 Year 07 Month 12 Day

Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2015 Year 07 Month 14 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

To assess the following efficacy
- SVR, end of treatment response, ALT normalization rate
- Above efficacy variables by HCV genotype and viral load
To confirm advanced liver disease (decompensated LC, development of HCC ) during follow up (by June 2014)
To assess factors influencing efficacy and safety
Identification and confirmation of host-, virus- and treatment-related factors (e.g. age, body weight, gender, pre-treatment viral load, ALT ratio, liver fibrosis stage, on-treatment response and treatment exposure) influencing virological response, SVR and relapse
Correlation between overall treatment duration after HCV RNA becomes negative and SVR by genotype
Correlation of cumulative ribavirin and cumulative peginterferon dose with SVR by genotype.
To confirm frequency of hematological test
To confirm frequency and reason for dose modification

Management information

Registered date

2011 Year 09 Month 01 Day

Last modified on

2019 Year 04 Month 05 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007396

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name