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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000692
Receipt No. 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

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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
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 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
URL(English) https://upload.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


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