UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study-
Title of the study (Brief title)	Retreatment of Patients who failed DCV/ASV with LDV/SOF+RBV
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C
Basic objectives2	Others
Basic objectives -Others	Consider exploratory to the preceding administration of ribavirin
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	sustained virologic response 12 weeks after treatment
Key secondary outcomes	virologic response at 1,2,3,4,8,12weeks and sustend virologic response Safety ( moniterd clinical and laboratory evaluation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ledipasvir/Sofosbuvir with Ribavirin
Interventions/Control_2	Ledipasvir/Sofosbuvir with Ribavirin (Precedence)
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 failed Daclatasvir/Asunaprevir with chronic hepatitis C
Key exclusion criteria	1) Patients with serious renal disease(eGFR<30mL/min/1.73m2) or dialysis 2) Patients with haemoglobinopathies (thalassemia, sickle cell anemia) 3) Decompenstated liver cirrhosis 4) HCC, malignat tumor 5) Patients with Hb less than 10 g/dl. 6) Pregnant or lactating women and women who may be pregnant 7) Judged by investigator not to be appropriate for inclusion in this study
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuaki Chayama
Organization	graduate school of biomedical science, Hiroshima university
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Email	chayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Yoshiiku Kawakami
Organization	graduate school of biomedical science, Hiroshima university
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Homepage URL
Email	kamy4419@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima liver study group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 12 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The overall SVR12 rate was 86.7% (26/30). Large decreases in mean log10 HCV RNA levels were observed in patients without cirrhosis, and the SVR12 rate for these patients was 100% (12/12). In cases of cirrhosis, SVR12 rate was 72.2%(13/18) .The common factors in treatment failure cases were the presence of liver cirrhosis and both NS5A L31M/I and Y93H RAVs. The frequency of RAVs did not change before and after treatment among patients who relapsed.
Other related information

Management information
Registered date	2016 Year 04 Month 18 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024931