UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012384 |
|---|---|
| Receipt number | R000014481 |
| Scientific Title | Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2016/05/25 19:37:32 |
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Basic information
Public title
Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
Acronym
SMV RCT study
Scientific Title
Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
Scientific Title:Acronym
SMV RCT study
Region
| Japan |
Condition
Condition
Chronic liver disorder infected with hepatitis C
virus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of two pegylated interferons in combination therapy with simprevir and ribavirin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication of hepatitis C
virus
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Simeprevir, RIbavirin, Pegylated interferon alpha 2a
Interventions/Control_2
Simeprevir, RIbavirin, Pegylated interferon alpha 2b
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
Patients with more than 5 Log copies/ml of genotype 1 HCV
Key exclusion criteria
pregnant woman
Uncontrolled heart diseases
Chronic renal failure
Depression
Hepatic cirrhosis
Hepatocellular carcinoma
Autoimmune hepatitis
Drug allergy for ribavirin, interferon, and simeprevir
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3435
Homepage URL
atamori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In total, 151 patients were randomly assigned to the P2aR (n = 76) or P2bR group (n = 75). Peginterferon alpha-2a or alpha-2b in combination with SMV + ribavirin therapy showed identical antiviral effects in patients with chronic hepatitis C. Also, the incidence of adverse events was identical for both regimens.
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 | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2016 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014481
