UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

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	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Email

Public contact
Name of contact person	Naoki Hiramatsu
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Homepage URL
Email	hiramatsu@gh.med.osaka-u.ac.jp

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

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)

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 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 19 Day
Last modified on	2016 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008628