A Phase 3 interventional study of ombitasvir/paritaprevir/ritonavir, dasabuvir and sofosbuvir (SOF) in Chronic Hepatitis C Virus (HCV Infection Genotype 1), sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 10 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir · Drug: sofosbuvir (SOF) · Drug: ribavirin (RBV)
tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Also known as: Viekira PAK, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, dasabuvir also known as ABT-333
tablet
tablet
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Subjects With On-treatment Virologic Failure
Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
Time frame: 6 weeks
Percentage of Subjects With Post-treatment Relapse
Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment
Time frame: Up to 12 weeks after last actual dose of active study drug
A total 10 participants were enrolled in the first arm (ombitasvir/paritaprevir/r, dasabuvir, and SOF plus RBV for 6 weeks); based on inadequate efficacy in the first arm, subsequent arms (4 weeks of treatment; with or without RBV) were not enrolled per protocol.
| Milestone | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
| percentage of participants | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 80 |
Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
| percentage of participants | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Percentage of Subjects With On-treatment Virologic Failure | 0 |
Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment
| percentage of participants | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Percentage of Subjects With Post-treatment Relapse | 20 |
Collected over Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | — | 1/10 (10%) | 10/10 (100%) |
| Event | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| ANXIETYPsychiatric disorders | 1/10 |
| PHYSICAL ASSAULTSocial circumstances | 1/10 |
| Event | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| FATIGUEGeneral disorders | 5/10 |
| INSOMNIAPsychiatric disorders | 5/10 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 3/10 |
| HEADACHENervous system disorders | 3/10 |
| CONSTIPATIONGastrointestinal disorders | 2/10 |
| GASTROOESOPHAGEAL REFLUX DISEASEGastrointestinal disorders | 2/10 |
| NAUSEAGastrointestinal disorders | 2/10 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 2/10 |
| IRRITABILITYPsychiatric disorders | 2/10 |
| DYSPNOEA EXERTIONALRespiratory, thoracic and mediastinal disorders | 2/10 |
| Age, Continuous(years) | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Mean | 46.4 ± 11.30 |
| Sex: Female, Male(Participants) | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV |
|---|---|
| Female | 4 |
| Male | 6 |
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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