UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Michihiro Suzuki
Organization	St. Marianna University School of Medicine
Division name	Division of gastroenterology and Hepatology
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	Hiroki　Ikeda
Organization	St. Marianna University School of Medicine
Division name	Division of gastroenterology and Hepatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025131