UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022418 |
|---|---|
| Receipt number | R000025831 |
| Scientific Title | Efficacy and safety of ledipasvir/sofosubuvir/ribavirin combination therapy for failures to daculatasvir/asunaprevir combination therapy. |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2019/03/04 21:03:13 |
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Basic information
Public title
Efficacy and safety of ledipasvir/sofosubuvir/ribavirin combination therapy for failures to daculatasvir/asunaprevir combination therapy.
Acronym
LDV/SOF/RBV for failures to DCV/ASV.
Scientific Title
Efficacy and safety of ledipasvir/sofosubuvir/ribavirin combination therapy for failures to daculatasvir/asunaprevir combination therapy.
Scientific Title:Acronym
LDV/SOF/RBV for failures to DCV/ASV.
Region
| Japan |
Condition
Condition
Patients infected with HCV genotype 1, who failed to daculatasvir/asunaprevir comnination therapy.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate efficacy and safety of ledipasvir/sofosbuvir/ribavirin combination therapy for failures infected with HCV genotype 1 to daculatasvir/asunaprevir combination therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rates of HCV-RNA negativity at 12 weeks after the completion of therapy (Sustained virological response rates).
Key secondary outcomes
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
Ribavirin add-on ledipasvir/sofosubuvir 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
1) Age of 20 years or more.
2) Patients who have provided written informed consent to participate in this study.
3) HCV genotype 1
4) Chronic hepatitis or compensated cirrhosis.
5) Failures to daculatasvir/asunaprevir combination therapy.
Key exclusion criteria
1) Patients with history of hypersensitivity to HCV NS5A inhibitors/ NS5B inhibitors/ ribavirin.
2) Patients with hepatocellular carcinoma.
3) Females who are pregnant or lactating.
4) Patients with renal dysfunction (eGFR <50 mL/min/1.73m2) and hemodialysis patients.
5) Unsuitable patients for this study who were evaluated by principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Akuta |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
TEL
044-877-5111
norioakuta@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Akuta |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
TEL
044-877-5111
Homepage URL
norioakuta@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital, Department of Hepatology.
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 | 05 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025831
