| Trial ID: | L1441 |
| Source ID: | NCT02806362
|
| Associated Drug: |
Ombitasvir/Paritaprevir/Ritonavir
|
| Title: |
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
|
| Acronym: |
GIFT-R
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Hepatitis C Virus
|
| Interventions: |
DRUG: Ombitasvir/paritaprevir/ritonavir
|
| Outcome Measures: |
Primary: Percentage of participants achieving a 12-week sustained virologic response (SVR12)., SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug., 12 weeks after the last dose of study drug | Secondary: Percentage of participants with on-treatment virologic failure, On-treatment virologic failure was defined as the following: Confirmed increase from nadir in HCV RNA (2 consecutive HCV RNA measurements greater than 1 log10 IU/mL above nadir) at any time point during treatment; or Confirmed HCV RNA greater than or equal to LLOQ after HCV RNA is less than LLOQ during treatment; or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks of treatment., Up to Week 12|Percentage of participants with relapse, Participants with a confirmed HCV RNA greater than or equal to the LLOQ between Final treatment visit and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA less than LLOQ at Final treatment visit., Up to 12 weeks after the last dose of study drug
|
| Sponsor/Collaborators: |
Sponsor: AbbVie
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-09
|
| Completion Date: |
2018-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-12-05
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02806362
|
