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This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | Experimental | ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. | 12 weeks after last dose of study drug |
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China. | 24 weeks after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On Treatment Virologic Failure | On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method. |
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Inclusion Criteria:
Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
Chronic HCV-infection prior to study enrollment.
Screening laboratory result indicating HCV genotype 1b-infection.
Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
Per local standard practice, documentation of cirrhosis by one of the following methods:
Exclusion Criteria:
HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)
Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:
Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29909549 | Derived | Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r/ABT-267 + ABT-333 + Ribavirin | ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based ribavirin (RBV) divided twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2015 | Feb 26, 2018 |
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| ABT-333 | Drug | Tablet |
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| ribavirin | Drug | Tablet |
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| Within 12 weeks after first dose of study drug |
| Percentage of Participants With Virologic Relapse | Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. | Within 12 weeks after the last dose of study drug |
| Percentage of Participants With Virologic Relapse by Post-Treatment Week 24 | Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. | Within 24 weeks after the last dose of study drug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r/ABT-267 + ABT-333 + Ribavirin | ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. | Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Primary | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China. | Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after last dose of study drug |
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| Secondary | Percentage of Participants With On Treatment Virologic Failure | On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method. | Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks after first dose of study drug |
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| Secondary | Percentage of Participants With Virologic Relapse | Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. | Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Only completers (ie, participants who were dosed with study drug at least 77 days) were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks after the last dose of study drug |
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| Secondary | Percentage of Participants With Virologic Relapse by Post-Treatment Week 24 | Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. | Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Only completers (ie, participants who were dosed with study drug at least 77 days) were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 24 weeks after the last dose of study drug |
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Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
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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 | ABT-450/r/ABT-267 + ABT-333 + Ribavirin | ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks | 0 | 104 | 4 | 104 | 71 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| FOOD POISONING | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| SPINAL COLUMN INJURY | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 19.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 19.0 | Systematic Assessment |
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| BILIRUBIN CONJUGATED INCREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| BLOOD BILIRUBIN UNCONJUGATED INCREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| RETICULOCYTE COUNT INCREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal 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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| RASH | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2016 | Feb 26, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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