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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | C000000305 |
Receipt No. | 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 | 2006/01/15 |
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 |
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Condition | |||
Condition | Hepatitis C virus related chronic liver disease | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |