UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012384
Receipt number 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 19:37:32

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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 or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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