UMIN-CTR Clinical Trial

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
Email

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
Email	tookimura-gi@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital
Institute
Department

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
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	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
Date of protocol fixation	2005 Year 12 Month 20 Day
Date of IRB
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	2006 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000386

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.