Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
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|ClinicalTrials.gov Identifier: NCT02609659|
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : October 18, 2017
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus (HCV)||Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir Drug: ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)|
|Actual Study Start Date :||October 28, 2015|
|Actual Primary Completion Date :||October 7, 2016|
|Actual Study Completion Date :||December 28, 2016|
Experimental: 3-DAA + RBV 600 mg
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.
- Percentage of Participants With Hemoglobin < 10 g/dL During Treatment [ Time Frame: up to 12 weeks ]The percentage of participants with hemoglobin <10 g/dL during treatment is provided.
- Mean Change in Hemoglobin Values From Baseline to End of Treatment [ Time Frame: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks) ]The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.
- Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]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, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609659
|Study Director:||AbbVie Inc||AbbVie|