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
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
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
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
