UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015627 |
|---|---|
| Receipt number | R000018162 |
| Scientific Title | Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection |
| Date of disclosure of the study information | 2014/11/07 |
| Last modified on | 2017/02/10 11:45:53 |
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Basic information
Public title
Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Acronym
Effectiveness and safety of daclatasvir plus asunaprevir
Scientific Title
Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Scientific Title:Acronym
Effectiveness and safety of daclatasvir plus asunaprevir
Region
| Japan |
Condition
Condition
Chronic HCV genotype 1b infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to evaluate the virological efficacy and safety of daclatasvir plus asunaprevir.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sustained virological response (SVR)
Key secondary outcomes
1. Efficacy and safety for patients with older or CKD (HD)
2. Predictive factor of SVR
3. Evaluation of adverse effects
4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir
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
24-week course of daclatasvir (Daklinza; Bristol-Myers Squibb, Tokyo, Japan) (60 mg tablet once daily) and asunaprevir (Sunvepra; Bristol-Myers) (100 mg softgel capsule twice daily)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Ineligible/Intolerance for interferon-based therapy
2. Non-virological response for the past interferon-based treatment
3. This study will be explained and informed consent needs to be obtained from all the patients.
Key exclusion criteria
1. Decompensated cirrhosis (Child B or C)
2. ALT level of more than five times the upper limit of normal range
3. Severe kidney damage (eGFR<30)
4. Coinfection with HBV or HIV
5. Women with pregnancy or breast feeding
6. Patients using contraindication drugs
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
TEL
+81926425909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Ogawa |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
TEL
+81926425909
Homepage URL
eogawa@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
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
九州大学関連肝疾患治療研究会（KULDS）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 07 | 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
* Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A RAVs or simeprevir failure, irrespective of fibrosis status.
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
| 2014 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 06 | 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
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018162
