UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012668 |
|---|---|
| Receipt number | R000014812 |
| Scientific Title | Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2017/06/29 17:49:30 |
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Basic information
Public title
Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Acronym
Simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Scientific Title
Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Scientific Title:Acronym
Simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Region
| Japan |
Condition
Condition
chronic infection with hepatitis C virus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure.
- Investigating the factors for sustained virological response.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Simeprevir plus Peg-IFN combination therapy
Interventions/Control_2
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) Hemodialysis patients
2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml
Key exclusion criteria
1) Patients with co-infection with hepatitis B virus or human immunodeficiency virus or alcoholic liver disorder or autoimmune hepatitis.
2) Patients with uncompensated cirrhosis or hepatic failure
3) Patients with multiple organ failure or immunological deficiency
4) Patients with severe depression or past history of psychiatric disorder
5) Patients in pregnancy or lactating or patients who expect to become pregnant
Target sample size
45
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
Yamadaoka 2-2, 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
Gastroenterology and Hepatology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka, Japan
TEL
06-6879-3621
Homepage URL
hiramatsu@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
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 | 12 | Month | 25 | 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 | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014812
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
