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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018476
Receipt No. 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

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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
Email 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
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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