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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013715
Receipt No. R000016011
Scientific Title Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C
Date of disclosure of the study information 2014/04/14
Last modified on 2018/10/18

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Basic information
Public title Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C
Acronym Investigation of the therapeutic effects regarding a new triple therapy for chronic hepatitis C
Scientific Title Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C
Scientific Title:Acronym Investigation of the therapeutic effects regarding a new triple therapy for chronic hepatitis C
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Comparison of clinical effects between the two pegylated-interferons (-alpha2a and -alpha2b) in the Peg-IFN/RBV/simeprevir triple therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of sustained viral response (having undetectable serum HCV-RNA 24 weeks after the end of treatment)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Peg-IFN-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks treatment
Interventions/Control_2 Peg-IFN-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients having genotype 1b high virus titer chronic hepatitis C (HCV-RNA more than 5 LogIU/mL) who did not achieve early viral response and failed in viral eradication with the previous Peg-IFN plus RBV treatment and who met the following inclusion criteria: laboratory data before study treatment of white blood cell count over 3,000/mm3, neutrophil count over 1,500/mm3,platelet count over 90,000/mm3, and hemoglobin over 12 g/dL
Key exclusion criteria Patients who did not fulfill the criteria to receive the approved Peg-IFN-alpha/RBV/simeprevir treatment
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo College of Medicine
Division name Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
Zip code
Address Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL 0798-45-6472
Email nishiguc@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirayuki Enomoto
Organization Hyogo College of Medicine
Division name Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
Zip code
Address Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL 0798-45-6472
Homepage URL
Email enomoto@hyo-med.ac.jp

Sponsor
Institute Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine
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
2014 Year 04 Month 14 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
Due to the development of DAAs, we could not recruit the scheduled number of patients and terminated the study before proceeding to the analysis.
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
2013 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 16 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 04 Month 14 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016011

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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