UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021969 |
|---|---|
| Receipt number | 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 18:35:08 |
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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
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
kamy4419@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima liver study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024931
