![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | C000000203 |
Receipt No. | R000000262 |
Scientific Title | Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2015/08/30 |
Basic information | ||
Public title | Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation | |
Acronym | GLSG.2004.Pegasys | |
Scientific Title | Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation | |
Scientific Title:Acronym | GLSG.2004.Pegasys | |
Region |
|
Condition | ||
Condition | chronic hepatitis C,cirrhosis,hepatocellular carcinoma | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | randomized controlled study of PEG-IFN-alpha-2a for prevention of hepatocellular carcinoma |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Prevention of hepatocellular carcinoma |
Key secondary outcomes | HCV-RNA,ALT,fibrosis |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | PEG-IFN-alpha2a | |
Interventions/Control_2 | no treatment | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | HCV-RNA(+) hepatocarcinoma
Child-Pugh A 3months after HCC treatment |
|||
Key exclusion criteria | ANC<750/mm3,Plt<50,000/mm3
Child-Pugh B,C |
|||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Gunma University Graduate School of Medicine | ||||||
Division name | Department of Medicine and Molecular Science | ||||||
Zip code | |||||||
Address | 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan | ||||||
TEL | 027-220-8127 | ||||||
satoken@gunma-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Gunma University Graduate School of Medicine | ||||||
Division name | Department of Medicine and Molecular Science | ||||||
Zip code | |||||||
Address | 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan | ||||||
TEL | 027-220-8127 | ||||||
Homepage URL | |||||||
satoken@gunma-u.ac.jp |
Sponsor | |
Institute | Gunma Liver Study Group |
Institute | |
Department |
Funding Source | |
Organization | Gunma Liver Study Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000262 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |