UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012878 |
|---|---|
| Receipt number | R000014518 |
| Scientific Title | Add-on effects of statin in simeprevir, peginterferon plus ribavirin combination therapy for chronic hepatitis C. |
| Date of disclosure of the study information | 2014/01/22 |
| Last modified on | 2025/08/18 09:32:55 |
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Basic information
Public title
Add-on effects of statin in simeprevir, peginterferon plus ribavirin combination therapy for chronic hepatitis C.
Acronym
Statin add onto simeprevir, peginterferon plus ribavirin therapy
Scientific Title
Add-on effects of statin in simeprevir, peginterferon plus ribavirin combination therapy for chronic hepatitis C.
Scientific Title:Acronym
Statin add onto simeprevir, peginterferon 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
To study add-on effects of fluvastatin in simeprevir, peg interferon plus ribavirin combination therapy for genotype 1 chronic hepatitis C by randomized, non-blind controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response (viral clearance rate on 24 weeks after treatment)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
fluvastatin, simeprevir, peginterferon and ribavirin
Interventions/Control_2
simeprevir, peginterferon and ribavirin
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
chronic hepatitis C patients, genotytpe 1
Key exclusion criteria
1. prior treatment containing telaprevir
2. pregnant or possibly pregnant
3. patients with fertile partner
4. patients allergic to ribavirin or other nucleoside analogues
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Sakamoto |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-716-1161
sakamoto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-716-1161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/28722780/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/28722780/
Number of participants that the trial has enrolled
61
Results
Thirty-one patients were allocated to the FLV add-on group and 29 patients were allocated to the control group. Baseline clinical factors, including median age, baseline platelet count, alanine aminotransferase level, HCV RNA titer, Fibrosis-4 index, and rate of IL28B minor genotype, were all similar between the two groups. The rapid virologic response, end-of-treatment response rates, SVR rates at 24 weeks after treatment, and safety profiles were also similar between the two groups.
Results date posted
| 2025 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 61 patients with a genotype 1b HCV infection were enrolled between July 2014 and June 2016.
Participant flow
A total of 61 patients with a genotype 1b HCV infection were enrolled between July 2014 and June 2016.
Of those 61 patients, one patient withdrew written consent, therefore, a total of 60 patients were randomized into the Peg-IFN/RBV/SMV group (control group) or Peg-IFN/RBV/SMV plus FLV add-on group (FLV add-on group).
.
Adverse events
In the FLV add-on group, one patient (3.2%) discontinued treatment because of a psychological disorder, and in the control group, two patients (6.9%) discontinued treatment because of retinopathy or incidence of HCC. No significant difference in the incidence of treatment discontinuation was observed between the two groups. Additionally, no patient had a lethal adverse event during treatment in this study. In both groups, one patient (3.2% and 3.4% in FLV add-on group and control group, respectively) experienced alanine aminotransferase elevation more than five times the upper limit of normal; however, the elevation normalized during treatment and the incidence of alanine aminotransferase elevation was not significantly different between the two groups. The most common adverse event in both groups was anemia, the incidence of which was not significantly different between the groups.
Outcome measures
SVR12
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014518
