| Trial ID: | L1292 |
| Source ID: | NCT03144635
|
| Associated Drug: |
Grazoprevir Plus Elbasvir
|
| Title: |
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03144635/results
|
| Conditions: |
Hepatitis C Viral|Chronic Kidney Disease stage3
|
| Interventions: |
DRUG: Grazoprevir plus Elbasvir
|
| Outcome Measures: |
Primary: Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months, We evaluated the serum endostatin at baseline and 3 months after the treatment initiation., 3 months|Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months, We evaluated eGFR level at baseline and 3 months after the treatment initiation., 3 months | Secondary: Sustained Virological Response-12 (SVR12), SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment., 3 months|Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months, We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation., 3 months|Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months, We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation., 3 months|Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12, We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Kyushu University | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-04-01
|
| Completion Date: |
2018-09-20
|
| Results First Posted: |
2019-06-03
|
| Last Update Posted: |
2019-06-03
|
| Locations: |
Kyushu University Hospital, Fukuoka, 812-8582, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT03144635
|
