UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000305 |
|---|---|
| Receipt number | R000000386 |
| Scientific Title | Efficacy of PEG-IFN alpha-2b and Ribavirin after curative treatment of hepatitis C virus related hepatocellular carcinoma |
| Date of disclosure of the study information | 2006/01/16 |
| Last modified on | 2022/07/28 18:24:44 |
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Basic information
Public title
Efficacy of PEG-IFN alpha-2b and Ribavirin after curative treatment of hepatitis C virus related hepatocellular carcinoma
Acronym
PEG-IFN alpha-2b and Ribavirin Therapy
Scientific Title
Efficacy of PEG-IFN alpha-2b and Ribavirin after curative treatment of hepatitis C virus related hepatocellular carcinoma
Scientific Title:Acronym
PEG-IFN alpha-2b and Ribavirin Therapy
Region
| Japan |
Condition
Condition
Hepatitis C virus related chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of PEG-IFN alpha-2b and Ribavirin for the recurrence of hepatocellular carcinoma, survival, and safety in patients with chronic liver disease after curative treatment of hepatitis C virus related hepatocellular carcinoma by surgical resection or radiofrequency ablation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease free survival
Key secondary outcomes
1) Survival
2) Sustained viral response
3) Sustained biochemical response
4) Safety
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG-IFN alpha-2b 1.0microgram/kg/w+ Ribavirin 400-600mg/day for 48 weeks(Patients with age: under 65 years old, hemoglobin concentration: equal or over 10g/dl, white blood cell count: equal or over 1,500/mm3, blood neutrophil count: equal or over 750/mm3, and platelet count: equal or over 80,000/mm3)
Interventions/Control_2
PEG-IFN alpha-2b 0.5microgram/kg/w+ Ribavirin 200mg/day for 48 weeks (Patients other than age: under 65 years old, hemoglobin concentration: equal or over 10g/dl, white blood cell count: equal or over 1,500/mm3, blood neutrophil count: equal or over 750/mm3, and platelet count: equal or over 80,000/mm3)
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
Criteria before treatment of hepatocellular carcinoma
1) Patients with first occurrence or first recurrence (after more than 1 year from treatment of hepatocellular carcinoma) of hepatocellular carcinoma
2) Patients without portal venous invasion
Criteria after treatment of hepatocellular carcinoma
1) Patients with curative treatment of hepatocellular carcinoma by surgical resection or radiofrequency ablation
2) Patients passed 8 to 12 weeks after treatment of hepatocellular carcinoma and observed no recurrence by imaging test
3) Patients who can treat within 8 weeks after confirming no recurrence by imaging test
4) Hepatitis C virus related chronic liver disease patients with detectable serum HCV RNA
Key exclusion criteria
1) Patients with concomitant carcinoma except for hepatocelular carcinoma
2) Patients with experience of systemic anti-cancer drug treatment for hepatocellular carcinoma
3) Pregnant or lactating women and women who may be pregnant
4) Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment
5) Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment
6) History of hypersensitivity to ribavirin or other nucleoside analogues (acyclovir, ganciclovir, vidarabine etc.)
7) Inadequately controlled cardiac disease (myocardial infarction, cardiac failure, arrhythmia etc.)
8) Hemoglobinopathy (thalassemia, drepanocytic anemia etc.)
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) Autoimmune hepatitis
13) History of hypersensitivity to PEG-IFN alpha-2b or other interferons
14) History of hypersensitivity to biological products such as vaccine
15) Patients receiving shosaiko-to
16) Judged by investigator to be not appropriate for inclusion in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Osaki |
Organization
Osaka Red Cross Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Fudegasaki-cho 5-30, Tennoji-ku, Osaka, Japan
TEL
06-6774-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Kimura |
Organization
Osaka Red Cross Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Fudegasaki-cho 5-30, Tennoji-ku, Osaka, Japan
TEL
06-6774-5111
Homepage URL
tookimura-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2006 | Year | 01 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2005 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2005 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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
| 2006 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000386
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