| Trial ID: | L1552 |
| Source ID: | NCT02580474
|
| Associated Drug: |
Daclatasvir Plus Asunaprevir
|
| Title: |
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hepatitis C
|
| Interventions: |
DRUG: Daclatasvir plus Asunaprevir
|
| Outcome Measures: |
Primary: the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment, 36 Week | Secondary: To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment, 36 Week|Percentage of subjects with ALT normalization at each visit from the baseline, 4, 12, 24, 36 week|Change in HCV RNA at each visit from the baseline, 4, 12, 24, 36 week|Percentage of subjects who experience viral breakthrough at each visit from the baseline, 4, 12, 24, 36 week|Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from, 4, 12, 24, 36 week
|
| Sponsor/Collaborators: |
Sponsor: Myeong Jun Song | Collaborators: Bristol-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam National University Hospital|Konyang University Hospital|Eulji University Hospital|Saint Vincent's Hospital, Korea|Konkuk University Hospital|Cheongju St. Mary's Hospital, Cheongju, Korea|Severance Hospital|Korea University Guro Hospital|Eulji General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-02
|
| Completion Date: |
2018-04
|
| Results First Posted: |
|
| Last Update Posted: |
2018-07-18
|
| Locations: |
Myeong Jun Song, Daejeon, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02580474
|
