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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003797-32 | EudraCT Number |
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The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-493/ABT-530 | Experimental | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493/ABT-530 | Drug | Tablet; ABT-493 coformulated with ABT-530 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 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 increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28818546 | Background | Forns X, Lee SS, Valdes J, Lens S, Ghalib R, Aguilar H, Felizarta F, Hassanein T, Hinrichsen H, Rincon D, Morillas R, Zeuzem S, Horsmans Y, Nelson DR, Yu Y, Krishnan P, Lin CW, Kort JJ, Mensa FJ. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017 Oct;17(10):1062-1068. doi: 10.1016/S1473-3099(17)30496-6. Epub 2017 Aug 14. | |
| 31568620 |
| Label | URL |
|---|---|
| Related Info | View source |
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This study included a 35-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-493/ABT-530 | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was 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 levels < LLOQ at the end of treatment, excluding reinfection. | From the end of treatment through 12 weeks after the last dose of study drug |
| Derived |
| Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18. |
| 30977945 | Derived | Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20. |
| 30923816 | Derived | Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022. |
| 30529905 | Derived | Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24. |
| 30012435 | Derived | Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-493/ABT-530 | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) 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 |
| |||||||||||||||||
| 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 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders. | 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 increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | All participants who received at least 1 dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was 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 levels < LLOQ at the end of treatment, excluding reinfection. | All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 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 16 weeks).
TEAEs and TESAEs are defined as any AE or SAE event 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 | ABT-493/ABT-530 | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. | 11 | 146 | 63 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ENDOPHTHALMITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| RECTAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| TUMOUR MARKER INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| ALCOHOL ABUSE | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
| C000654128 | glecaprevir and pibrentasvir |
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