UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011246 |
|---|---|
| Receipt number | 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 13:34:27 |
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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
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
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
The department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka Suita Osaka Japa
TEL
06-6879-3621
Homepage URL
hiramatsu@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
The department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013182
