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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003370-33 | EudraCT Number |
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This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | Experimental | Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-Treatment Virologic Failure During Treatment Period | On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Dumas, PhD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28416221 | Background | Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).
A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROENTERITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
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| dasabuvir | Drug | Tablet |
|
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| Up to 8 weeks while on treatment |
| Percentage of Participants With Post-Treatment Relapse12 | Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. | Up to 12 weeks after last dose of study drug |
| Percentage of Female Participants Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug |
| Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | Baseline and 12 weeks after the last actual dose of study drug |
| Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population | On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method. | Up to 8 weeks while on treatment |
| Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population | Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. | Up to 12 weeks after last dose of study drug |
| Percentage of Female Participants Responding With SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug |
| Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | Baseline and 12 weeks after the last actual dose of study drug |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With On-Treatment Virologic Failure During Treatment Period | On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. | ITT population: all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 8 weeks while on treatment |
|
|
|
| Secondary | Percentage of Participants With Post-Treatment Relapse12 | Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. | ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after last dose of study drug |
|
|
|
| Secondary | Percentage of Female Participants Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 12 weeks after the last actual dose of study drug |
|
|
|
| Other Pre-specified | Percentage of Participants Who Achieve SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
|
|
| Other Pre-specified | Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population | On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method. | The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 8 weeks while on treatment |
|
|
|
| Other Pre-specified | Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population | Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. | The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after last dose of study drug |
|
|
|
| Other Pre-specified | Percentage of Female Participants Responding With SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
|
|
| Other Pre-specified | Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 12 weeks after the last actual dose of study drug |
|
|
|
| 2 |
| 166 |
| 70 |
| 166 |
| SYNCOPE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 19.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 19.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |