UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000692
Receipt number R000000826
Scientific Title A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.
Date of disclosure of the study information 2007/04/26
Last modified on 2010/11/16 18:43:02

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Basic information

Public title

A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.

Acronym

A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.

Scientific Title

A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.

Scientific Title:Acronym

A phase II/III clinical study of R442(Pegylated Interferon alfa-2a) for patients with chronic hepatitis B.

Region

Japan


Condition

Condition

chronic hepatitis B

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

(1)Evaluate efficacy (non-inferiority)
and safety of R442 compared to
Interferon alfa in HBe antigen-
positive patients.
(2)Evaluate efficacy and safety of R442
in HBe antigen-negative patients.
(3)Evaluate pharmacokinetics of R442 in
patients with chronic hepatitis B.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

(1)HBe antigen-positive patients
Combined response* after 24 weeks of
follow-up
*Defined by seroconversion to anti-HBe,
hepatitis B virus(HBV)-DNA
<5.0 log copies/mL and normalization
of ALT
(2)HBe antigen-negative patients.
1) HBV-DNA <4.3 log copies/mL after
24 weeks of follow-up
2) Normalization of ALT after 24
weeks of follow-up

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

7

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

R442 180mcg once weekly for 48 weeks in HBe antigen-positive patients.

Interventions/Control_2

R442 90mcg once weekly for 48 weeks in HBe antigen-positive patients.

Interventions/Control_3

R442 180mcg once weekly for 24 weeks in HBe antigen-positive patients.

Interventions/Control_4

R442 90mcg once weekly for 24 weeks in HBe antigen-positive patients.

Interventions/Control_5

Interferon alfa 6MIU three times week for 24 weeks in HBe antigen-positive patients.
(Unblinded)

Interventions/Control_6

R442 180mcg once weekly for 48 weeks in HBe antigen-negative patients.

Interventions/Control_7

R442 90mcg once weekly for 48 weeks in HBe antigen-negative patients.

Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients aged over 20 years-old with serum HBs antigen-positive,HBs Ab (Antibody)-negative of screening,elevated ALT twice within 180 days,and proven chronic hepatitis B.
1) HBe antigen-positive patients:HBsAg-positive,HBsAb-negative,DNA polymerase-positive,HBV-DNA=>5.7 log copies/mL
2) HBe antigen-negative patients : HBe antigen-negative,HBV-DNA=>5.0 log copies/mL

Key exclusion criteria

Neutrophil count <1,500 cells/mm3,platelet count < 90,000 cells/mm3, hemoglobin concentration <10 g/dL, hepatitis C co-infection, decompensated liver disease, history of organ transplant, creatinine clearance < 50 mL/min, sever psychiatric disease, diabetes needed pharmacotherapy, poorly controlled hypertention, malignant tumor, severe cardiac or chronic pulmonary disease, immunologically mediated disease, cerebral stroke or retinopathy. Treated by pegylated interferon in the past.

Target sample size

260


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Hayashi

Organization

Osaka University Graduate School Of Medicine

Division name

Department Of Gastroenterology And Hepatology

Zip code


Address

2-2,Yamadaoka,Suita,Osaka,565-0871,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

CHUGAI PHARMACEUTICAL CO.LTD.

Division name

Clinical Research Dept.4

Zip code


Address


TEL


Homepage URL


Email

clinical-trials@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

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2007 Year 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2006 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2007 Year 05 Month 01 Day

Last follow-up date

2010 Year 11 Month 01 Day

Date of closure to data entry

2010 Year 11 Month 01 Day

Date trial data considered complete

2011 Year 01 Month 01 Day

Date analysis concluded

2011 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 04 Month 26 Day

Last modified on

2010 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name