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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021969
Receipt No. R000024931
Scientific Title Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study-
Date of disclosure of the study information 2016/04/19
Last modified on 2017/08/22

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Basic information
Public title Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study-
Acronym Retreatment of Patients who failed DCV/ASV with LDV/SOF+RBV
Scientific Title Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study-
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuaki Chayama
Organization graduate school of biomedical science, Hiroshima university
Division name Department and medicine and molecular science
Zip code
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
1st name
Middle name
Last name Yoshiiku Kawakami
Organization graduate school of biomedical science, Hiroshima university
Division name Department and medicine and molecular science
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2016 Year 03 Month 12 Day
Date of IRB
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

Other
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

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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