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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021790
Receipt No. R000025131
Scientific Title Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/06

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Basic information
Public title Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy
Acronym LDV/SOF+RBV combination therapy for patients with chronic hepatitis C who failed to DAC/ASV therapy
Scientific Title Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy
Scientific Title:Acronym LDV/SOF+RBV combination therapy for patients with chronic hepatitis C who failed to DAC/ASV therapy
Region
Japan

Condition
Condition Patients with chronic hepatitis C, who failed to DCV/ASV therapy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of add-on RBV in sofosbuvir plus ledipasvir therapy for patients with a chronic HCV genotype 1 infection, who failed to DCV/ASV therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the sustained virologic response (SVR) rate after 12 weeks since administration
Key secondary outcomes 1) SVR 24 rates
2) Virological response rates at 1, 2, 4, 8 week and EOTR
3) Incidence of adverse effects
4) resistance-associated variant

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 LDV/SOF plus RBV for 12 weeks
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 Patients who satisfy all the inclusion criteria and meet none of the exclusion criteria are eligible for the study.
(inclusion criteria)
1) Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy
2) HCV-RNA positive
3) Patients who are 20 years of age or older at the time of informed consent
4) ECOG performance status 0 or 1
5) Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
Key exclusion criteria 1) HBV or HIV co-infected patients
2) Patients with a hepatocellular carcinoma, at the start of treatment
3) Patients with pregnancy, or possibility to be pregnant, or on breast feeding
4) Patients with a history of hypersensitivity to other nucleoside-analogue
5) Patients with severe renal dysfunction or need to be treated on hemodialysis
6) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
7) Patients with abnormal hemoglobin disease
8) Patients with severe depression, suicidal ideation, or severe mental illness
9) Patients with severe hepatic impairment
10) Patients with Autoimmune hepatitis
11) Patients taking medicine as below: rifampicin, phenytoin, carbamazepine, seiyouotogisou-including foods
12) Patients who took investigational agents within 3 months prior to this study
13) Patients who are unsuitable for study entry in the opinion of the principal investigator, for this study due to any other reason
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Suzuki
Organization St. Marianna University School of Medicine
Division name Division of gastroenterology and Hepatology 
Zip code
Address 2-16-1 Sugao, Miyamae-2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japank
TEL +81449778111
Email michstmu@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Ikeda
Organization St. Marianna University School of Medicine
Division name Division of gastroenterology and Hepatology 
Zip code
Address 2-16-1 Sugao, Miyamae-2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan
TEL +81449778111
Homepage URL
Email ikedahi@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
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
Email

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 聖マリアンナ医科大学病院(神奈川県)、川崎市立多摩病院(神奈川県)、聖マリアンナ医科大学横浜市西部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 06 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
Date of protocol fixation
2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 06 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
2016 Year 04 Month 06 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025131

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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