Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OCR16260 | Other Identifier | University of Florida |
Not provided
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| AbbVie | INDUSTRY |
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The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
The primary purpose of this study is to compare the efficacy and safety of glecaprevir and pibrentasvir (G/P) for 12 weeks to G/P for 16 weeks in non-cirrhotic NS5A (non-structural protein 5a)-inhibitor plus sofosbuvir ± RBV (Ribavirin) treatment-experienced adults with HCV genotype 1 (GT1) infection, and to compare the efficacy and safety of G/P with RBV for 12 weeks to G/P without RBV for 16 weeks in NS5A-inhibitor plus sofosbuvir (SOF) ± RBV treatment-experienced adults with compensated cirrhosis and GT1 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: G/P 300 mg/120 mg QD for 12 Wks | Experimental | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. |
|
| Arm B: G/P 300 mg/120 mg QD for 16 Wks | Experimental | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) |
|
| Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | Experimental | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) |
|
| Arm D: G/P 300 mg/120 mg QD for 16 Wks | Experimental | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir (G/P) 300mg/120mg | Drug | daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants | Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA \ | Up to 28 weeks |
| Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks | Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks | Up to 28 weeks |
| Tolerability of G/P +/-RBV | Number of subjects who discontinued G/P due to adverse events | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects) | Difference in % of subjects with on-treatment virologic failure further defined as either 1)Breakthrough a)Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < Lower Limit of Quantification (LLOQ) at some point during the Treatment Period or confirmed increase from nadir in HCV RNA (two consecutive measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period, or b) a single value indicating viral breakthrough (≥ 100 IU/mL or > 1 log10 above nadir), followed by patient status of 'Lost to Follow-up', the latter not requiring confirmation by a proximate measurement) or 2) End of Treatment Failure defined as HCV RNA ≥ LLOQ at end of treatment and following at least 6 weeks of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| David R Nelson, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34023351 | Derived | Wang GP, Schnell GL, Kort JJ, Sidhu GS, Schuster L, Tripathi RL, Larsen L, Michael LC, Bergquist K, Magee A, Patel CB, Whitlock JA, Tamashiro R, Peter JA, Fried MW, Nelson DR. Linkage of resistance-associated substitutions in GT1 sofosbuvir + NS5A inhibitor failures treated with glecaprevir/pibrentasvir. J Hepatol. 2021 Oct;75(4):820-828. doi: 10.1016/j.jhep.2021.04.057. Epub 2021 May 21. | |
| 31401140 |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: G/P 300 mg/120 mg QD for 12 Wks | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| FG001 | Arm B: G/P 300 mg/120 mg QD for 16 Wks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2018 | Nov 4, 2019 |
Not provided
Main Study Up to 225 subjects will be enrolled into 4 study arms A, B, C and D with Glecaprevir/Pibrentasvir (G/P) with or without Ribavirin (RBV).
About 75-90 non-cirrhotic subjects will be randomized in a 2:1 ratio to Arms A and B, and about 110-135 compensated cirrhotic subjects will be randomized in a 1:1 ratio to Arms C and D.
Non-cirrhotic subjects will be randomized 2:1 to:
Arm A: G/P 300 mg/120 mg Once a day for 12 weeks
Arm B: G/P 300 mg/120mg Once a day for 16 weeks
Subjects with compensated cirrhosis will be randomized 1:1 to:
Arm C: G/P 300 mg/120 mg QD + weight-based RBV (Ribavirin) Twice a day (1000 mg or 1200 mg total daily dose) for 12 weeks
Arm D: G/P 300 mg/120 mg QD for 16 weeks Retreatment sub-study Up to 11 subjects who still have hepatitis C virus after being treated in the Main study will have the option to enter the Retreatment sub-study and receive G/P plus Sofosbuvir and with or without RBV.
Not provided
Not provided
Not provided
Not provided
|
| Ribavirin 200Mg Tablet | Drug | Weight-based 1000-1200 mg |
|
|
| Up to 28 weeks |
| Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects | Difference in Post-treatment relapse (defined as confirmed HCV RNA>= Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at end of treatment, excluding subjects with subjects with reinfection) | Up to 28 weeks |
| Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects | Difference in percentage of cirrhotic subjects experiencing on-treatment virologic failure (confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment) after 12 weeks of G/P with or without RBV for 12 weeks versus 16 weeks of G/P | Up to 28 weeks |
| Difference in % of Relapse Between Cirrhotic Arms C & D | Difference in the percentage of compensated cirrhotic subjects with post-treatment relapse (defined as confirmed HCV RNA>=Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after last dose of study drug among subjects who completed treatment as planned with HCV RNA\ | Up to 28 weeks |
| Difference in SVR12 Rates for 12-wk vs 16 wk | Difference in proportions of SVR 12 rates will be determined for 12-week vs. 16-week treatment durations using contrasts within a logistic regression model with cirrhosis status and HCV genotype (1b vs non-1b) as factors | 28 weeks |
| San Francisco |
| California |
| 94143 |
| United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | United States |
| UF Health Jacksonville-Gastroenterology Emerson | Jacksonville | Florida | 32207 | United States |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Atlanta Medical Center | Atlanta | Georgia | 303012 | United States |
| Atlanta Gastro Associates | Atlanta | Georgia | 30308 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The Johns Hopkins Hospital/John G. Bartlett Specialty Practice | Baltimore | Maryland | 21287 | United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5601 | United States |
| Univ. of Minnesota Health Clinics and Surgery Center, Inc. | Minneapolis | Minnesota | 55455 | United States |
| Southern Therapy and Advanced Research | Jackson | Mississippi | 39216 | United States |
| Northwell Health - Sandra Atlaas Bass Center for Liver Diseases | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Weill Cornell Medicine, Hepatology | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| University of Pennsylvania-Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Bon Secours Liver Institute of Virginia | Richmond | Virginia | 23226 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0341 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Derived |
| Lok AS, Sulkowski MS, Kort JJ, Willner I, Reddy KR, Shiffman ML, Hassan MA, Pearlman BL, Hinestrosa F, Jacobson IM, Morelli G, Peter JA, Vainorius M, Michael LC, Fried MW, Wang GP, Lu W, Larsen L, Nelson DR. Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy. Gastroenterology. 2019 Dec;157(6):1506-1517.e1. doi: 10.1053/j.gastro.2019.08.008. Epub 2019 Aug 8. |
Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| FG002 | Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg |
| FG003 | Arm D: G/P 300 mg/120 mg QD for 16 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: G/P 300 mg/120 mg QD for 12 Wks | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| BG001 | Arm B: G/P 300 mg/120 mg QD for 16 Wks | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| BG002 | Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg |
| BG003 | Arm D: G/P 300 mg/120 mg QD for 16 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HCV Genotype, non-1b | HCV Genotype was characterized as 1b and non-1b | Count of Participants | Participants |
| |||||||||||||||
| HCV RNA | Baseline HCV RNA, log10 IU/ML, MEDIAN (RANGE) | Median | Full Range | LOG10 IU/mL |
| ||||||||||||||
| PLATELET | Platelets collected at Baseline Lab Draw | Median | Full Range | 10E3 cells/uL |
| ||||||||||||||
| ALT | Median | Full Range | u/L |
| |||||||||||||||
| APRI | AST to Platelet Ratio Index (APRI) (AST Level (IU/L)/AST (Upper Limit of Normal) (IU/L))/Platelet Count (109/L) * 100 | Median | Full Range | Index |
| ||||||||||||||
| Estimated GFR | Estimated Glomerular Filtration Rate | Median | Full Range | ml/min/1.73M2 |
| ||||||||||||||
| HIV | Number of patients with HIV at baseline | Count of Participants | Participants |
| |||||||||||||||
| Albumin | Median | Full Range | g/dL |
|
| 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 | SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants | Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA \ | These analyses were completed on Modified ITT -Genotype Population defined as all treated subjects representing their actual study regimen and who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 28 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks | Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks | Cirrhotic subjects achieving Virologic Response at Post-Treatment Week 12 | Posted | Count of Participants | Participants | Up to 28 weeks |
|
| ||||||||||||||||||||||||||||||||
| Primary | Tolerability of G/P +/-RBV | Number of subjects who discontinued G/P due to adverse events | Posted | Count of Participants | Participants | Up to 16 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects) | Difference in % of subjects with on-treatment virologic failure further defined as either 1)Breakthrough a)Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < Lower Limit of Quantification (LLOQ) at some point during the Treatment Period or confirmed increase from nadir in HCV RNA (two consecutive measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period, or b) a single value indicating viral breakthrough (≥ 100 IU/mL or > 1 log10 above nadir), followed by patient status of 'Lost to Follow-up', the latter not requiring confirmation by a proximate measurement) or 2) End of Treatment Failure defined as HCV RNA ≥ LLOQ at end of treatment and following at least 6 weeks of treatment. | Analysis was performed the study population "as treated" further defined as mITT-all subjects representing their actual study regimen and who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 28 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects | Difference in Post-treatment relapse (defined as confirmed HCV RNA>= Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at end of treatment, excluding subjects with subjects with reinfection) | Analysis performed on any subject with study drug duration of 77 days or greater for Arm A or 105 days or greater for Arm B | Posted | Count of Participants | Participants | Up to 28 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects | Difference in percentage of cirrhotic subjects experiencing on-treatment virologic failure (confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment) after 12 weeks of G/P with or without RBV for 12 weeks versus 16 weeks of G/P | Analysis was performed the study population "as treated" further defined as mITT-all subjects representing their actual study regimen and who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 28 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Difference in % of Relapse Between Cirrhotic Arms C & D | Difference in the percentage of compensated cirrhotic subjects with post-treatment relapse (defined as confirmed HCV RNA>=Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after last dose of study drug among subjects who completed treatment as planned with HCV RNA\ | Posted | Count of Participants | Participants | Up to 28 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Difference in SVR12 Rates for 12-wk vs 16 wk | Difference in proportions of SVR 12 rates will be determined for 12-week vs. 16-week treatment durations using contrasts within a logistic regression model with cirrhosis status and HCV genotype (1b vs non-1b) as factors | Modified Intent to Treat Population (mITT) analysis (All subjects enroll in Main study receiving at least one dose of study drug and according to the treatment arm in which they were actually treated) | Posted | Count of Participants | Participants | 28 weeks |
|
142 days
Not provided
Not provided
| 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: G/P 300 mg/120 mg QD for 12 Wks | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks. Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily | 1 | 78 | 4 | 78 | 50 | 78 |
| EG001 | Arm B: G/P 300 mg/120 mg QD for 16 Wks | Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily | 0 | 49 | 2 | 49 | 32 | 49 |
| EG002 | Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily Ribavirin 200Mg Tablet: Weight-based 1000-1200 mg | 0 | 21 | 1 | 21 | 17 | 21 |
| EG003 | Arm D: G/P 300 mg/120 mg QD for 16 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily | 0 | 29 | 0 | 29 | 17 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chronic Obstruction Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| HCC final outcome Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment | Death related to HCC |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
This study did not include a group that received 16 weeks of glecaprevir and pibrentasvir with ribavirin.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Morelli | UF Hepatology Research at CTRB | 3522739508 | LAUREN.MORELLI@MEDICINE.UFL.EDU |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2019 | Nov 4, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
| C000654128 | glecaprevir and pibrentasvir |
| D012254 | Ribavirin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
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| OG003 | Arm D: G/P 300 mg/120 mg QD for 16 Wks | Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks) Glecaprevir/Pibrentasvir (G/P) 300mg/120mg: daily |
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