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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038604
Receipt No. R000043998
Scientific Title Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/17

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Basic information
Public title Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Acronym Harvoni in Genotype 2 HCV patients
Scientific Title Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Scientific Title:Acronym Harvoni in Genotype 2 HCV patients
Region
Japan

Condition
Condition Patients With Hepatitis C Virus Genotype 2 Infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 fficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and efficacy of ledipasvir-sofosbuvir for 12 weeks treatment with Japanese GT2 patients
Key secondary outcomes Completion rate for treatment completion (without discontinuation of safety reason).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 More than 20 years old and had chronic infection with HCV genotype 2.
With or without Child-Pugh A compensated cirrhosis.
Body weight more than 40 kg.
Written informed consent
Key exclusion criteria Prior exposure to a direct-acting antiviral agent targeting HCV NS5A or NS5B
Decompensated cirrhosis
Creatinine clearance (Cockcroft-Gault) less than 30 mL/min
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Toyoda
Organization Ogaki Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 503-8502
Address 4-86 Minaminokawa, Ogaki, Gifu, Japan
TEL +81-584-81-3341
Email tkumada@he.mirai.ne.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kumada
Organization Gifu Kyoritsu University
Division name Department of Nursing, Faculty of Nursing
Zip code 503-8550
Address 5-50, Kitagata-cho, Ogaki city, Gifu prefecture
TEL +81-584-77-3512
Homepage URL
Email takashi.kumada@gmail.com

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

Funding Source
Organization Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ogaki Municipal Hospital
Address -86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel +81-584-81-3341
Email clinical-trial@omh.ogaki.gifu.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
2019 Year 12 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 27 Day
Date of IRB
2018 Year 10 Month 26 Day
Anticipated trial start date
2020 Year 03 Month 31 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ehime Prefectural Central Hospital
Kagawa Prefectural Central Hospital

Management information
Registered date
2019 Year 11 Month 17 Day
Last modified on
2019 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043998

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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