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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001527-77 | EudraCT Number |
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This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-DAA (Direct Acting Antivirals) with or without RBV | Experimental | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir | Drug | tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. | Up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Cohen, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291369 | Derived | Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5. | |
| 26976799 |
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The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3-DAA ± RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| dasabuvir | Drug | tablet |
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| Ribavirin | Drug | tablet |
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| Percentage of Participants With Post-Treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. | Within 12 weeks after the last dose of study drug |
| Derived |
| Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E. Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology. 2016 Jun;150(7):1590-1598. doi: 10.1053/j.gastro.2016.02.078. Epub 2016 Mar 11. |
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| NOT COMPLETED |
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Safety and demographic analyses were performed on safety population, which is the same as the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3-DAA ± RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or ribavirin (RBV; dosed divided twice a day) for 12 or 24 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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| 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 (SVR12) Weeks Post-treatment | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | All randomized participants who received at least one dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. | All randomized participants who received at least one dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With Post-Treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. | All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks after the last dose of study drug |
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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 | 3-DAA +/- RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks | 17 | 68 | 51 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
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| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| CARDIAC TAMPONADE | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| VOLVULUS | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| LIVER INJURY | Hepatobiliary disorders | MedDra 19.1 | Systematic Assessment |
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| ARTERIOVENOUS GRAFT SITE INFECTION | Infections and infestations | MedDra 19.1 | Systematic Assessment |
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| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDra 19.1 | Systematic Assessment |
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| PERITONITIS BACTERIAL | Infections and infestations | MedDra 19.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDra 19.1 | Systematic Assessment |
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| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDra 19.1 | Systematic Assessment |
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| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
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| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
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| MENTAL STATUS CHANGES | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
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| ACCELERATED HYPERTENSION | Vascular disorders | MedDra 19.1 | Systematic Assessment |
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| HYPERTENSIVE CRISIS | Vascular disorders | MedDra 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDra 19.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDra 19.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDra 19.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDra 19.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDra 19.1 | 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 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| D005355 | Fibrosis |
| 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 |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C000607373 | Viekira Pak |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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