UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018476 |
|---|---|
| Receipt number | R000021395 |
| Scientific Title | Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin for patients with chronic hepatitis C genotype 1 and low hemoglobin level |
| Date of disclosure of the study information | 2015/07/29 |
| Last modified on | 2019/08/02 16:05:10 |
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Basic information
Public title
Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin for patients with chronic hepatitis C genotype 1 and low hemoglobin level
Acronym
Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin
Scientific Title
Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin for patients with chronic hepatitis C genotype 1 and low hemoglobin level
Scientific Title:Acronym
Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin
Region
| Japan |
Condition
Condition
Patients with chronic hepatitis C virus infection
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assessment of efficacy and safety of simeprevir with pegylated interferon and low dose of ribavirin in patients with chronic hepatits C and low hemoglobin level.
To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virologic response rate
Key secondary outcomes
The factor associated with sustained virologic response
Safety
Emergence of drug-resistant virus
Cumulative incidence of hepatocellular carcinoma
The factor associated with incidence of hepatocellular carcinoma
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 with pegylated interferon alfa and low dose of ribavirin
Simeprevir: 100mg/day, orally, 12 weeks
Pegylated interferon: alfa-2a 180mcg/week, alfa-2b 1.5mcg/kg/week, subcutaneous infusion, 24 weeks
Ribavirin: If hemoglobin is between 10g/dl and 12g/dl, ribavirin 400mg/day, orally, 24 weeks.
If hemoglobin is between 8.5g/dl and 10g/dl, ribavirin 200mg/day, orally, 24 weeks.
Simeprevir, Pegylated interferon plus ribavirin 12 weeks and following Pegylated interferon plus ribavirin 12 weeks, total 24 weeks treatement
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) Patients with 20 years of age and older
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) Patients with less than 12 g/dl of hemoglobin
5) Eligible patients for interferon and ribavirin
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) Severe multisystem disease, Severe immunodeficiency
6) Contraindication to pegylated interferon
7) Contraindication to ribabirin
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) Severe multisystem disease, Severe immunodeficiency
6) Contraindication to pegylated interferon
7) Contraindication to ribabirin
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
81-6-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Sakamori |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
81-6-6879-3621
Homepage URL
sakamori@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid from Japan Agency fir Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Janssen Pharmaceutical K.K.
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2015 | Year | 07 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2015 | Year | 07 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021395
