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This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. |
|
| Arm B | Active Comparator | ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
|
| Arm C | Active Comparator | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 DAA | Drug | ABT-450/r/ABT-267 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm | SVR12 was defined as 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. | 12 weeks after last dose |
| 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 after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | Screening until 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm | On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment. |
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Inclusion Criteria:
Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
Subjects must meet one of the following:
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Kopecky-Bromberg, PhD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28404110 | Background | Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16. |
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Safety population: All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. |
| FG001 | Arm B | ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| FG002 | Arm C | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. |
| BG001 | Arm B |
| 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 With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm | SVR12 was defined as 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. | Intent-to-treat population: all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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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 | Arm A | ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 DAA) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| RBV |
| Drug |
Ribavirin tablets |
|
| Up to 12 or 24 weeks after first dose |
| Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm | Post-treatment relapse was defined as 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 < LLOQ at the end of treatment. | Up to 12 weeks after first dose |
| Lost to Follow-up |
|
ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| BG002 | Arm C | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| OG002 | Arm C | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
|
|
| Primary | 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 after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | Safety Population: all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Screening until 30 days after last dose |
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm | On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment. | Intent-to-treat population: all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 or 24 weeks after first dose |
|
|
|
| Secondary | Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm | Post-treatment relapse was defined as 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 < LLOQ at the end of treatment. | Intent-to-treat population: all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after first dose |
|
|
|
| 2 |
| 100 |
| 79 |
| 100 |
| EG001 | Arm B | ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. | 0 | 31 | 24 | 31 |
| EG002 | Arm C | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. | 2 | 29 | 25 | 29 |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| APNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA version 19.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA version 19.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA version 19.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA version 19.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA version 19.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
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| CHROMATURIA | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| POLYURIA | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
|
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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |