UMIN-CTR Clinical Trial

Public title

Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy for aged patients with chronic hepatitis C genotype 1

Acronym

Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy

Scientific Title

Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy for aged patients with chronic hepatitis C genotype 1

Scientific Title:Acronym

Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy

Region

Japan

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examining the anti-viral efficacy and safety between with or without of telaprevir combination with pegylated interferon plus ribavirin by sorting according to virologic response for aged patients scheduled telaprevir with pegylated interferon plus ribavirin therapy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The group of patients treated with pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy

The patients with HCV RNA decrease more than 3 log/IU/ml at 4 weeks of pegylated interferon plus ribavirin therapy: Continuating pegylated interferon plus ribavirin therapy
Pegylated interferon alpha 2b: 1.5 mcg/kg/w i.s.
Ribavirin: Body weight; less than 60 Kg, 600 mg/day p.o., more than 60 Kg and less than 80 kg, 800 mg/day p.o., more than 80 kg, 1000 mg/day, p.o.
Treatment duration: 48 weeks or 72 weeks according to response-guided therapy

The patients with HCV RNA decrease less than 3 log/IU/ml at 4 weeks of pegylated interferon plus ribavirin therapy: Switching to telaprevir with pegylated interferon plus ribavirin therapy
Pegylated interferon alpha 2b: 1.5 mcg/kg/w i.s.
Ribavirin: Body weight; less than 60 Kg, 600 mg/day p.o., more than 60 Kg and less than 80 kg, 800 mg/day p.o., more than 80 kg, 1000 mg/day, p.o.
Telaprevir: 1500 mg/day p.p.
Treatment duration: Pegylated interferon and Ribavirin; 24 weeks, Telaprevir; 12 weeks

Interventions/Control_2

The group of patients treated with pegylated interferon plus ribavirin therapy
Pegylated interferon alpha 2b: 1.5 mcg/kg/w i.s.
Ribavirin: Body weight; less than 60 Kg, 600 mg/day p.o., more than 60 Kg and less than 80 kg, 800 mg/day p.o., more than 80 kg, 1000 mg/day, p.o.
Treatment duration: 48 weeks or 72 weeks according to response-guided therapy

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients over 65 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 and positive of HBs antigen
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 or less than 50 ml/min of creatinine clearance
8) Patients whose hemoglobin levels are less than 12 g/dL
9) Patients whose platelet counts are less than 15,000 /microL
10) Patients whose neutrophil counts are less than 1,500 /microL
11) Patients whom investigator disqualified

Target sample size

410

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, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3621

Email

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, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3621

Homepage URL

Email

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

02

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

02

Month

10

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

2013

Year

06

Month

15

Day

Date of closure to data entry

2013

Year

06

Month

15

Day

Date trial data considered complete

2013

Year

06

Month

15

Day

Date analysis concluded

2013

Year

06

Month

15

Day

Other related information

Registered date

2012

Year

02

Month

19

Day

Last modified on

2016

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008628