UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007313
Receipt number R000008617
Scientific Title Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial
Date of disclosure of the study information 2012/02/16
Last modified on 2017/07/25 13:41:06

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Basic information

Public title

Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial

Acronym

Trial comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1

Scientific Title

Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial

Scientific Title:Acronym

Trial comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparing treatment efficacy of telaprevir dose reduction regimen with that of telaprevir standard dose regimen on a telaprevir with pegylated interferon and ribavirin therapy for treatment-naive patients with chronic hepatitis C genotype 1

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

-Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment

Key secondary outcomes

-Early virologic response; the rate of undetectable HCV RNA at 12 weeks of treatment
-End of treatment virologic response rate; the rate of undetectable HCV RNA at end of treatment
-The rate of patients without treatment discontinuation due to adverse event
-The rate of adverse events
-Drug adherence
-Transition of quality of life


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

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

<Telaprevir standard dose regimen>
Telaprevir: 2250mg/day p.o., 12weeks
Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg - 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks

Interventions/Control_2

<Telaprevir dose reduction regimen>
Telaprevir: 1500mg/day p.o., 12weeks
Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg - 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks

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

1) Patients over 20 years old
2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml
3) Patients without previous history of pegylated interferon plus ribavirin therapy

Key exclusion criteria

1) Patients with co-infection with hepatitis B virus
2) Patients with co-infection with human immunodeficiency virus
3) Patients with alcoholic liver disorder or autoimmune hepatitis
4) Patients with uncompensated cirrhosis or hepatic failure
5) Patients with multiple organ failure or immunological deficiency
6) Patients with severe depression or past history of psychiatric disorder
7) Patients with chronic renal failure
8) Patients in pregnancy or lactating or patients who expect to become pregnant
9) Patients whose hemoglobin levels are less than 12 g/dL
10) Patients whose platelet counts are less than 15,000 /microL
11) Patients whose neutrophil counts are less than 1,500 /microL
12) Patients whom investigator disqualified

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuo Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-2 ,Yamadaooka, Suita, Osaka, Japan

TEL

06-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Hiramatsu

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-2, Yamadaooka, Suita, Osaka, Japan

TEL

06-6879-3621

Homepage URL


Email

hiramatsu@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

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

大阪大学医学部附属病院(大阪府)
国立病院機構大阪医療センター (大阪府)
国立病院機構大阪南医療センター (大阪府)
国立病院機構南和歌山医療センター (和歌山県)
大阪労災病院 (大阪府)
関西労災病院 (兵庫県)
大阪警察病院 (大阪府)
大阪府立成人病センター (大阪府)
大阪府立急性期・総合医療センター (大阪府)
公立学校共済組合近畿中央病院 (兵庫県)
国家公務員共済組合連合会大手前病院 (大阪府)
大阪厚生年金病院 (大阪府)
県立西宮病院 (兵庫県)
箕面市立病院 (大阪府)
市立池田病院 (大阪府)
市立伊丹病院 (大阪府)
市立豊中病院 (大阪府)
市立吹田市民病院 (大阪府)
市立芦屋病院 (兵庫県)
西宮市立中央病院 (兵庫県)
八尾市立病院 (大阪府)
東大阪市立総合病院 (大阪府) 
住友病院 (大阪府)
NTT西日本大阪病院 (大阪府)
大阪府済生会千里病院 (大阪府) 
加納総合病院 (大阪府)
明和病院 (兵庫県) 
大阪回生病院 (大阪府)
笹生病院 (兵庫県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 16 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


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

2011 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2017 Year 12 Month 01 Day

Date analysis concluded

2018 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 16 Day

Last modified on

2017 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name