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Clinical Trial Details

Trial ID: L1689
Source ID: NCT02487199
Associated Drug: Ombitasvir/Paritaprevir/Ritonavir And Dasabuvir
Title: Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02487199/results
Conditions: Hepatitis C Virus (HCV)
Interventions: DRUG: ombitasvir/paritaprevir/ritonavir and dasabuvir|DRUG: ombitasvir/paritaprevir/ritonavir
Outcome Measures: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12), 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. Participants with missing data after backward imputation were imputed as nonresponders., 12 weeks after the last actual dose of study drug|Number of Participants With Adverse Events, An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section., Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks) | Secondary: Percentage of Participants With On-treatment Virologic Failure, On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment or confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment., 12 weeks|Percentage of Participants With Post-treatment Relapse, Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment., From the end of treatment through 12 weeks after the last dose of study drug
Sponsor/Collaborators: Sponsor: AbbVie
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-09-30
Completion Date: 2016-12-05
Results First Posted: 2017-12-04
Last Update Posted: 2017-12-04
Locations:
URL: https://clinicaltrials.gov/show/NCT02487199