UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012937 |
|---|---|
| Receipt number | R000015134 |
| Scientific Title | Efficacy and safety of Simeprevir/PEG alpha-IFN-2a/RBV therapy for patients with chronic hepatitis C after resection of hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2014/12/20 08:57:17 |
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Basic information
Public title
Efficacy and safety of
Simeprevir/PEG alpha-IFN-2a/RBV
therapy for patients with chronic hepatitis C after resection of hepatocellular carcinoma
Acronym
Simeprevir/PEG alpha-IFN-2a/RBV
therapy for patients with chronic hepatitisC after resection of HCC
Scientific Title
Efficacy and safety of
Simeprevir/PEG alpha-IFN-2a/RBV
therapy for patients with chronic hepatitis C after resection of hepatocellular carcinoma
Scientific Title:Acronym
Simeprevir/PEG alpha-IFN-2a/RBV
therapy for patients with chronic hepatitisC after resection of HCC
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Simeprevir/PEG-IFNalpha-2a/RBV
therapy for patients with chronic hepatitis C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sustained virological response rate
Key secondary outcomes
Intrahepatic recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG IFN alpha-2a 180microgram/w+Ribavirin+Simeprevir 100mg/day
Interventions/Control_2
Daclatasvir 60mg/day + Asunaprevir 200mg/day
Interventions/Control_3
Observation Group
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis C after resection of hepatocellular carcinoma, are fit with all criteria.
1.Ages >=20,80<=
2.3 month after complete response to resection confirmed by imaging
3.Platelet counts >=90000/mm3(interferon group only)
4.Neutrophil counts >=1500/mm3(interferon group only)
5.Hemoglobin concentration >= 12g/dL(interferon group only)
6.Having received adequate explanation of the contents of the trial and given their written consent.
Key exclusion criteria
1.Concomitant herbal medication of Sho-saiko-to.
2.History of interstitial pneumonia
3.Autoimmune hepatitis
4.Allegic to vaccine or biological preperations.
5.Uncontrolled cardiopathy.
6.Hemoglobinopathy.
7.Chronic renal failure or renal dysfunction with creatinine clearance <=50mL/min.
8.Severe depression or psychosomatic disorders.
9.Patients with moderate liver diseases.(Child-Pugh grade BorC)
10.Patient with a history of photosensitivity
11.Women of childbearing potential and pregnancy, lactating women.
12.Drug allegy against interferon or nucleoside analog.
13.Patients receiving rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, systemic administration of dexamethasone, azole antifungal drug, clarithromycin, erythromycin, diltiazem, verapamil hydrochloride, cobicistat included drugs,HIV Protease inhibitor, modafinil, nonnucleoside reverse transcriptase inhibitor(except for rilpivirine hydrochloride), bosentan hydrate, St John's Wort included foods, cyclosporine, flecainide, propafenone.
14.Other conditions considered
inappropriate by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
Shinmachi 2-5-1, Hirakata City, Osaka Prefecture
TEL
072-804-0101
kaibori@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
Shinmachi 2-5-1, Hirakata City, Osaka Prefecture
TEL
072-804-0101
Homepage URL
kaibori@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
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
Osaka Medical College, Osaka City University Graduate School of Medicine, Osaka Red Cross Hospital Kinki University School of Medicine, Osaka University Graduate School of Medicine, Kobe City Medical Center General Hospital, Wakayama Medical University
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
| 2014 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 10 | Day |
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
| 2014 | Year | 01 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015134
