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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012384
Receipt No. R000014481
Scientific Title Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
Date of disclosure of the study information 2013/12/01
Last modified on 2016/05/25

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Basic information
Public title Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
Acronym SMV RCT study
Scientific Title Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
Scientific Title:Acronym SMV RCT study
Region
Japan

Condition
Condition Chronic liver disorder infected with hepatitis C
virus
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluation of two pegylated interferons in combination therapy with simprevir and ribavirin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication of hepatitis C
virus
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Simeprevir, RIbavirin, Pegylated interferon alpha 2a
Interventions/Control_2 Simeprevir, RIbavirin, Pegylated interferon alpha 2b
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with more than 5 Log copies/ml of genotype 1 HCV
Key exclusion criteria pregnant woman
Uncontrolled heart diseases
Chronic renal failure
Depression
Hepatic cirrhosis
Hepatocellular carcinoma
Autoimmune hepatitis
Drug allergy for ribavirin, interferon, and simeprevir
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Tamori
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL 06-6645-3811
Email atamori@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Tamori
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL 06-6645-3435
Homepage URL
Email atamori@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results In total, 151 patients were randomly assigned to the P2aR (n = 76) or P2bR group (n = 75). Peginterferon alpha-2a or alpha-2b in combination with SMV + ribavirin therapy showed identical antiviral effects in patients with chronic hepatitis C. Also, the incidence of adverse events was identical for both regimens.
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 Completed
Date of protocol fixation
2013 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 20 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
2013 Year 11 Month 22 Day
Last modified on
2016 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014481

Research Plan
Registered date File name
2016/05/25 TMC倫理委員会実施計画書第3版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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