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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003192-22 | EudraCT Number |
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A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir/Pibrentasvir for 8 Weeks | Experimental | Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label. |
|
| Glecaprevir/Pibrentasvir for 12 Weeks | Experimental | Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir | Drug | Fixed-dose combination tablets taken orally once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug. | 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment HCV Virologic Failure | HCV virologic failure was defined as one of the following conditions:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research & Education, Inc. /ID# 157042 | San Diego | California | 92105 | United States | ||
| Kaiser Permanente /ID# 157044 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30393106 | Background | Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2. | |
| 35174470 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Enrolled participants with genotype 5 or 6 hepatitis C (HCV) were assigned to treatment with glecaprevir/pibrentasir for either 8 weeks or 12 weeks based on cirrhotic status.
This study was conducted in 24 hospitals or clinics in Europe (Belgium, France), Oceania (Australia, New Zealand), North America (Canada, USA), South Africa, and southeast Asia (Singapore, Vietnam). Participants were screened between January 17, 2017, and December 26, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotype 5-infected | Participants with HCV genotype 5 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. |
| FG001 | Genotype 6-infected |
| 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 | Jul 28, 2017 | Jun 6, 2019 |
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|
| 8 or 12 weeks (depending on the treatment regimen) |
| Percentage of Participants With Relapse | Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed. | End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment. |
| San Diego |
| California |
| 92154 |
| United States |
| Zuckerberg San Francisco Gener /ID# 157040 | San Francisco | California | 94110 | United States |
| Cedars-Sinai Medical Center - West Hollywood /ID# 157045 | West Hollywood | California | 90048 | United States |
| Einstein Medical Center /ID# 157436 | Philadelphia | Pennsylvania | 19141 | United States |
| University of Washington /ID# 157041 | Seattle | Washington | 98109 | United States |
| Nepean Hospital Kingswood /ID# 157027 | Kingswood | New South Wales | 2747 | Australia |
| Royal Brisbane and Women's Hospital /ID# 157025 | Herston | Queensland | 4029 | Australia |
| Royal Melbourne Hospital /ID# 157024 | Parkville | Victoria | 3050 | Australia |
| AZ Groeninge /ID# 157029 | Kortrijk | 8500 | Belgium |
| UZ Leuven /ID# 157030 | Leuven | 3000 | Belgium |
| University of Calgary /ID# 157031 | Calgary | Alberta | T2N 4Z6 | Canada |
| Toronto General Hospital /ID# 157032 | Toronto | Ontario | M5G 2C4 | Canada |
| Hopital Haut-Lévêque /ID# 157035 | Pessac | Gironde | 33604 | France |
| CHU Estaing /ID# 157034 | Clermont-Ferrand | 63100 | France |
| Hopital Saint Antoine /ID# 157036 | Paris | 75012 | France |
| Hopital Beaujon /ID# 157028 | Clichy | Île-de-France Region | 92110 | France |
| Auckland Clinical Studies Ltd /ID# 157033 | Auckland | 1010 | New Zealand |
| National University Hospital /ID# 156855 | Singapore | 119074 | Singapore |
| Singapore General Hospital /ID# 157037 | Singapore | 169608 | Singapore |
| Wits Clinical Research Site /ID# 157038 | Johannesburg | Gauteng | 2193 | South Africa |
| University of Cape Town /ID# 157039 | Cape Town | Western Cape | 7925 | South Africa |
| National Hospital of Tropical Diseases /ID# 162282 | Hanoi | 100000 | Vietnam |
| Hoa Hao Medic Co. Ltd. /ID# 162283 | Ho Chi Minh City | 700000 | Vietnam |
| Tropical Diseases Hospital /ID# 162281 | Ho Chi Minh City | Vietnam |
| Derived |
| Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17. |
Participants with HCV genotype 6 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 5-infected | Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. |
| BG001 | Genotype 6-infected | Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cirrhosis Status | Count of Participants | Participants |
| ||||||||||||||||
| Prior HCV Treatment History | Count of Participants | Participants |
| ||||||||||||||||
| HCV Ribonucleic Acid (RNA) Concentration | Mean | Standard Deviation | log10 IU/mL |
|
| 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 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug. | All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen) |
|
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| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment HCV Virologic Failure | HCV virologic failure was defined as one of the following conditions:
| All enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 or 12 weeks (depending on the treatment regimen) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Relapse | Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed. | All enrolled participants who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment. |
|
From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
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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 | Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks. | 0 | 84 | 5 | 84 | 26 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| ESCHERICHIA PYELONEPHRITIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| GASTRIC ULCER HELICOBACTER | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| GIARDIASIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (21.0) | 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 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2018 | Jun 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| 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 |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
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| ≥ 65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| Multi-race |
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| Canada |
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| Vietnam |
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| Singapore |
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| Belgium |
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| United States |
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| South Africa |
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| Australia |
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| France |
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| Non-cirrhotic |
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| Experienced |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
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| Participants |
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