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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012937
Receipt No. 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

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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
Email 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
Email kaibori@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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