| Trial ID: | L1423 |
| Source ID: | NCT02207088
|
| Associated Drug: |
Ombitasvir/Paritaprevir/Ritonavir
|
| Title: |
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02207088/results
|
| Conditions: |
Chronic Hepatitis C|Hepatitis C Virus|Compensated Cirrhosis|Severe Renal Impairment|End-stage Renal Disease
|
| Interventions: |
DRUG: ombitasvir/paritaprevir/ritonavir|DRUG: dasabuvir|DRUG: Ribavirin
|
| Outcome Measures: |
Primary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment, SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug., 12 weeks after the last actual dose of study drug | Secondary: Percentage of Participants With On-treatment Virologic Failure, On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after \< LLOQ during treatment, confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment., Up to 24 weeks|Percentage of Participants With Post-Treatment Relapse, Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA \< LLOQ at the end of treatment., Within 12 weeks after the last dose of study drug
|
| Sponsor/Collaborators: |
Sponsor: AbbVie
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
68
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-09-23
|
| Completion Date: |
2016-12-06
|
| Results First Posted: |
2017-11-09
|
| Last Update Posted: |
2017-11-09
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02207088
|
