UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013088 |
|---|---|
| Receipt number | R000015271 |
| Scientific Title | Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C |
| Date of disclosure of the study information | 2014/02/06 |
| Last modified on | 2019/03/05 13:38:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Acronym
Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Scientific Title
Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Scientific Title:Acronym
Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Region
| Japan |
Condition
Condition
Patients with chronic hepatitis C virus infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of simeprevir with pegylated interferon and ribavirin in kidney transplant patients with chronic hepatits C.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virologic response rate 12(SVR12)
Key secondary outcomes
Base
Study type
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 with pegylated interferon alfa and ribavirin
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with 20-70 years of age
2) Naive patients with HCV egnotype 1 with viral load of more than 5 log IU/ml
3) Treatment-experienced patients with HCV egnotype 1
4) Eligible patients for interferon and ribavirin
Key exclusion criteria
1) Co-infection with hepatitis B virus
2) Co-infection with anti-human immunodeficiency virus
3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.)
4) Decompensated cirrhosis, Liver failure
5) Contraindication to pegylated interferon
6) Contraindication to ribavirin
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Takahara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Technology for Transplantation
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3746
takahara@att.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotsugu Ichimaru |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Technology for Transplantation
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3746
Homepage URL
ichimaru@att.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 02 | Month | 06 | 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
| 2014 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 06 | 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
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015271
