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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011246
Receipt No. R000013182
Scientific Title Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination therapy
Date of disclosure of the study information 2013/08/01
Last modified on 2017/07/25

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Basic information
Public title Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination therapy
Acronym Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues dual therapy with Peg-IFN plus RBV combination therapy
Scientific Title Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination therapy
Scientific Title:Acronym Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues dual therapy with Peg-IFN plus RBV combination 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 Evaluating the rate of patients completing treatment and the antiviral effect of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with PI, Peg-IFN plus RBV or dual therapy with Peg-IFN plus RBV
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - The rate of patients completing treatment
-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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 < Regimen for patients who discontinued triple therapy with protease inhibiter, Peg-IFN plus RBV >
- HCV-RNA disappeared within 12 treatment weeks
Interferon beta: 6M IU thrice a week, total of 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., total of 24weeks, 60kg - 80kg, 800mg/day p.o., total of 24 weeks, more than 80kg, 1000mg/day p.o., total of 24weeks

- HCV-RNA did not disappear at the point of discontinuation within 12 treatment weeks
Interferon beta: 6M IU/day 2weeks, followed by 6M IU thrice a week, total of 24weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., total of 24weeks, 60kg - 80kg, 800mg/day p.o., total of 24 weeks, more than 80kg, 1000mg/day p.o., total of 24weeks

< Regimen for patients who discontinued dual therapy with Peg-IFN plus RBV >
- HCV-RNA disappeared within 12 treatment weeks
Interferon beta: 6M IU thrice a week, total of 48weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., total of48weeks, 60kg - 80kg, 800mg/day p.o., total of 48weeks, more than 80kg, 1000mg/day p.o., total of 48weeks

- HCV-RNA disappeared during 12 - 36 treatment weeks
Interferon beta: 6M IU/day 2weeks, followed by 6M IU thrice a week, total of 72weeks
Ribavirin: Body weight; less than 60kg, 600mg/day p.o., total of 72weeks, 60kg - 80kg, 800mg/day p.o., total of 72 weeks, more than 80kg, 1000mg/day p.o., total of 72weeks
Interventions/Control_2 Patients without switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination 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
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 hepatitis C who discontinues triple therapy with protease inhibitor, Peg-IFN plus RBV or dual therapy with i Peg-IFN plus RBV
3)
- Patients who discontinued triple therapy within 12 treatment weeks
- Patients who discontinued triple therapy with disappearance of HCV-RNA after 12 treatment weeks
4)
- Patients who discontinued dual therapy within 36 treatment weeks regardless of disappearance of HCV-RNA
- Patients who discontinued dual therapy with disappearance of HCV-RNA after 36 treatment weeks
5) Reasons for discontinuing case is as below
1. depression
2. insomnia
3. severe fatigue
4. rash caused by pegylated interferon
5. platelet counts are less than 50,000/microL
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 8.5g/dL
10) Patients whose platelet counts are less than 25,000/microL
11) Patients whose neutrophil counts are less than 500 /microL
12) Patients whom investigator disqualified
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Osaka University Graduate School of Medicine
Zip code
Address 2-2 Yamadaoka Suita Osaka Japan
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoki Hiramatsu
Organization Osaka University Graduate School of Medicine
Division name The department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka Suita Osaka Japa
TEL 06-6879-3621
Homepage URL
Email hiramatsu@gh.med.osaka-u.ac.jp

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

Funding Source
Organization The 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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2013 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 13 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 07 Month 22 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013182

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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