UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001735 |
|---|---|
| Receipt number | R000002088 |
| Scientific Title | Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2024/09/07 17:51:53 |
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Basic information
Public title
Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy
Acronym
PEG-IFN alfa-2b + Ribavirin combination therapy after PSE or splenectomy
Scientific Title
Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy
Scientific Title:Acronym
PEG-IFN alfa-2b + Ribavirin combination therapy after PSE or splenectomy
Region
| Japan |
Condition
Condition
Chronic Hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of PEG-IFN alfa-2b + Ribavirin treatment between patients with chronic hepatitis C after partial splenic embolization(PSE) and splenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response(SVR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients are treated with PEG-IFN alfa-2b 1.0-1.5 microgram/kg/week + Ribavirin 400-1000/day. Treatment duration is 48-72 weeks for HCV genotype1 with high viral load and up to 24 weeks for HCV genotype1 with low viral load or genotype2.
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
1)Platelet count <80,000/mm3 before PSE or splenectomy
2)Platelet count 80,000/mm3 or more before initiation of PEG-IFN alfa-2b + Ribavirin treatment
3)High serum HCV levels of 5 log IU/ml or more(TaqMan) or previous IFN treatment failure
Key exclusion criteria
1)History of hypersensitivity to PEG-IFN alpha-2b or other interferons
2)History of hypersensitivity to biological products such as vaccine
3)Patients receiving shosaiko-to
4)Autoimmune hepatitis
5)Pregnant or lactating women and women who may be pregnant
6)History of hypersensitivity to ribavirin or other nucleoside analogs
7)Inadequately controlled cardiac disease
8)Hemoglobinopathy
9)Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less
10)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
11)Serious hepatic function disorder
12)Judged by investigator not to be appropriate for inclusion in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Tsutsui |
Organization
Tokushima Municipal Hospital
Division name
Department of Internal Medicine
Zip code
770-0006
Address
2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan
TEL
088-622-5121
amitsu6557@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Tsutsui |
Organization
Tokushima Municipal Hospital
Division name
Department of Internal Medicine
Zip code
760-8557
Address
2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan
TEL
09075718249
Homepage URL
amitsu6557@yahoo.co.jp
Sponsor or person
Institute
Tokushima Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Musashino Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima Municipal Hospital
Address
2-3 Kitajyousanjima-cho, Tokushima city, Tokushima
Tel
088-622-5121
amitsu6557@yahoo.co.jp
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
| 2009 | Year | 06 | Month | 01 | 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
| 2009 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2009 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002088
