Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004967-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks | Experimental | Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | 12 weeks after last dose of study drug |
| Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI. | 12 weeks after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josephs Hosp and Med Ctr /ID# 162762 | Phoenix | Arizona | 85013 | United States | ||
| Mayo Clinic Arizona /ID# 162314 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31682879 | Derived | Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2. |
Not provided
Not provided
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.
A total of 343 participants were enrolled and received ≥ 1 dose of study drug.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks. |
| 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 | Jun 11, 2018 | Jun 24, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks after last dose of study drug |
| Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure. | 12 weeks after the last dose of study drug |
| Percentage of Participants With On-treatment Virologic Failure in the ITT Population | On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | 8 weeks on treatment |
| 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 as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels < LLOQ at the end of treatment excluding participants who had been reinfected. | Up to 12 weeks after the last dose of study drug |
| Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. | 12 weeks after the last dose of study drug |
| Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. | 12 weeks after the last dose of study drug |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Liver Wellness Center /ID# 162244 | Little Rock | Arkansas | 72204 | United States |
| Felizarta /ID# 162295 | Bakersfield | California | 93301 | United States |
| VA Long Beach Healthcare System /ID# 162298 | Long Beach | California | 90822 | United States |
| Usc /Id# 162248 | Los Angeles | California | 90033 | United States |
| Kaiser Permanente - San Diego (Palm Ave) /ID# 162289 | San Diego | California | 92154 | United States |
| Stanford University School of Med /ID# 162209 | Stanford | California | 94305-2200 | United States |
| Cedars-Sinai Medical Center - West Hollywood /ID# 162313 | West Hollywood | California | 90048 | United States |
| University of Miami /ID# 162210 | Miami | Florida | 33136 | United States |
| Triple O Research Institute /ID# 162300 | West Palm Beach | Florida | 33407-3100 | United States |
| Piedmont Hospital /ID# 162646 | Atlanta | Georgia | 30309 | United States |
| Northwestern University Feinberg School of Medicine /ID# 162208 | Chicago | Illinois | 60611-2927 | United States |
| Unity Point Health /ID# 162247 | Des Moines | Iowa | 50309 | United States |
| The University of Iowa Hospita /ID# 162214 | Iowa City | Iowa | 52242 | United States |
| University of Louisville /ID# 162242 | Louisville | Kentucky | 40202 | United States |
| Louisiana Research Ctr. LLC /ID# 162567 | Shreveport | Louisiana | 71105-6800 | United States |
| Mercy Medical Center /ID# 162291 | Baltimore | Maryland | 21202 | United States |
| Mayo Clinic - Rochester /ID# 162251 | Rochester | Minnesota | 55905-0001 | United States |
| Southern Therapy and Advanced Research (STAR) LLC /ID# 162241 | Jackson | Mississippi | 39216 | United States |
| CHI Health Alegent Creighton /ID# 162286 | Omaha | Nebraska | 68124 | United States |
| Univ Nebraska Med Ctr /ID# 162285 | Omaha | Nebraska | 68198 | United States |
| Rnjms /Id# 162213 | Newark | New Jersey | 07103 | United States |
| Weill Cornell Medical College /ID# 161051 | New York | New York | 10021 | United States |
| Icahn School of Med Mt. Sinai /ID# 162294 | New York | New York | 10029 | United States |
| Montefiore Medical Center /ID# 162312 | The Bronx | New York | 10461 | United States |
| James J. Peters VA Medical Center /ID# 162644 | The Bronx | New York | 10468 | United States |
| Duke University Medical Center /ID# 162299 | Durham | North Carolina | 27710-3000 | United States |
| Cumberland Research Assoc /ID# 162212 | Fayetteville | North Carolina | 28304 | United States |
| Carolinas Center for Liver Dis /ID# 162569 | Statesville | North Carolina | 28677-3471 | United States |
| University Hospitals Cleveland /ID# 162243 | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic /ID# 162570 | Cleveland | Ohio | 44111 | United States |
| Osuchs /Id# 162284 | Tulsa | Oklahoma | 74127 | United States |
| Lehigh Valley Health Network /ID# 162603 | Allentown | Pennsylvania | 18103 | United States |
| Center for Liver Diseases, Oakland /ID# 162568 | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt Univ Med Ctr /ID# 162211 | Nashville | Tennessee | 37232-0011 | United States |
| Texas Digestive Disease Consul /ID# 162648 | Dallas | Texas | 75246-1613 | United States |
| University of Texas Health /ID# 162288 | Houston | Texas | 77030-1501 | United States |
| Virginia Commonwealth Univ /ID# 162215 | Richmond | Virginia | 23219 | United States |
| Univ of Wisconsin Hosp/Clinics /ID# 162645 | Madison | Wisconsin | 53792-0001 | United States |
| Tokuda Hospital Sofia /ID# 163422 | Sofia | 1407 | Bulgaria |
| DCC Fokus-5 - LZIP /ID# 163338 | Sofia | 1463 | Bulgaria |
| Univ Hosp for Active Treat /ID# 163330 | Sofia | 1527 | Bulgaria |
| UMHAT Sv. Ivan Rilski /ID# 163332 | Sofia | 1612 | Bulgaria |
| University of Calgary /ID# 161185 | Calgary | Alberta | T2N 4Z6 | Canada |
| Percuro Clinical Research, Ltd /ID# 161184 | Victoria | British Columbia | V8V 3M9 | Canada |
| Qe Ii Hsc /Id# 161178 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| The Ottawa Hospital Research /ID# 161179 | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto General Hospital /ID# 161182 | Toronto | Ontario | M5G 2C4 | Canada |
| Research Site s.r.o /ID# 163020 | Pilsen | 301 00 | Czechia |
| KlinMed s.r.o. /ID# 162893 | Prague | 120 00 | Czechia |
| Institut Klinicke a Experimeth /ID# 162900 | Prague | 140 21 | Czechia |
| CHR Orleans - Hopital de la Source /ID# 163072 | Orléans | Centre-Val de Loire | 45067 | France |
| Hôpital Purpan /ID# 163065 | Toulouse | Haute-Garonne | 31059 | France |
| CHU Amiens Picardie /ID# 163071 | Amiens | Somme | 80054 | France |
| CHU Estaing /ID# 163058 | Clermont-Ferrand | 63100 | France |
| Hospital Henri Mondor /ID# 163061 | Créteil | 94010 | France |
| Hopital de la Croix Rousse /ID# 163073 | Lyon | 69004 | France |
| General Hospital of Athens Laiko /ID# 162786 | Athens | Attica | 115 27 | Greece |
| General and Oncology Hospital /ID# 162784 | Kifissia | 14564 | Greece |
| Reg Gen Univ Hosp Larissa /ID# 162783 | Larissa | 41110 | Greece |
| Bioclinic Thessaloniki /ID# 162785 | Thessaloniki | 54622 | Greece |
| Budai Hepatologiai Centrum /ID# 166511 | Budapest | 1111 | Hungary |
| Szent Janos Korhaz /ID# 166542 | Budapest | 1125 | Hungary |
| St. James's Hospital /ID# 162619 | Dublin | Dublin | D08 E9P6 | Ireland |
| Beaumont Hospital /ID# 162618 | Dublin | D09 XR63 | Ireland |
| St Vincent's Hospital /ID# 162617 | Dublin | Ireland |
| Tel Aviv Sourasky Medical Ctr /ID# 162185 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus /ID# 162023 | Haifa | 3109601 | Israel |
| The Lady Davis Carmel MC /ID# 162017 | Haifa | 3436212 | Israel |
| Sheba Medical Center /ID# 162028 | Ramat Gan | 5262100 | Israel |
| Universita della Campania Luigi Vanvitelli /ID# 162337 | Naples | Campania | 80131 | Italy |
| A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335 | Bologna | Emilia-Romagna | 40138 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 162340 | Milan | Lombardy | 20162 | Italy |
| Istituto Clinico Humanitas /ID# 162336 | Rozzano | Milano | 20089 | Italy |
| Polo Universitario Luigi Sacco /ID# 162339 | Milan | 20157 | Italy |
| Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760 | Wroclaw | Lower Silesian Voivodeship | 50-349 | Poland |
| HepID - Diagnostyka I Terapia /ID# 162761 | Lublin | Lublin Voivodeship | 20-884 | Poland |
| Uniwersytecki Szpital Kliniczn /ID# 162757 | Bialystok | 15-276 | Poland |
| ID Clinic /ID# 162759 | Mysłowice | 41-406 | Poland |
| Centro Hosp de Lisboa Central /ID# 163770 | Lisbon | Lisbon District | 1169-050 | Portugal |
| Centro Hospitalar Lisboa Norte, EPE /ID# 163785 | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar do Porto EPE /ID# 163765 | Porto | 4099-001 | Portugal |
| Centro Hospitalar de Sao Joao /ID# 163766 | Porto | 4200-319 | Portugal |
| GHGCPR Research Institute /ID# 162608 | Ponce | 00716 | Puerto Rico |
| Instituto de Investigacion Cientifica del Sur /ID# 162566 | Ponce | 00730 | Puerto Rico |
| Klinical Investigations Group /ID# 162565 | San Juan | 00909 | Puerto Rico |
| Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484 | Sector 2 | Bucharest | 021105 | Romania |
| Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449 | Sector 2 | Bucharest | 021105 | Romania |
| Institutul Clinic Fundeni /ID# 163479 | Sector 2 | Bucharest | 022328 | Romania |
| Institutul Clinic Fundeni /ID# 163500 | Sector 2 | Bucharest | 022328 | Romania |
| Institutul Nat. de Boli Infectioase /ID# 163488 | Bucharest | 010825 | Romania |
| LLC Medical Company Hepatolog /ID# 161998 | Samara | Samara Oblast | 443063 | Russia |
| CBSI Central scientific and research institute of epidemiology /ID# 161996 | Moscow | 105275 | Russia |
| Central Clinical Hospital of R /ID# 163434 | Moscow | 117593 | Russia |
| Stavropol State Medical Univ /ID# 161999 | Stavropol | 355017 | Russia |
| RSAHI Consulting and Diagnostic Centre /ID# 161995 | Tyumen | 625026 | Russia |
| Hospital Parc de Salut del Mar /ID# 162198 | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron /ID# 162199 | Barcelona | 08035 | Spain |
| Hospital Universitario Reina S /ID# 162200 | Córdoba | 14004 | Spain |
| Hospital Donostia /ID# 162197 | Donostia / San Sebastian | 20080 | Spain |
| Hospital Univ Central Asturias /ID# 162195 | Oviedo | 33011 | Spain |
| China Medical University Hosp /ID# 162950 | Taichung | Taichung | 40447 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949 | Kaohsiung City | 80708 | Taiwan |
| Taipei Veterans General Hosp /ID# 162776 | Taipei | 11217 | Taiwan |
| Basildon University Hospital /ID# 162616 | Basildon | Essex | SS16 5NL | United Kingdom |
| The Royal Free Hospital /ID# 162614 | London | London, City of | NW3 2QG | United Kingdom |
| North Manchester General /ID# 163945 | Crumpsall | M8 5RB | United Kingdom |
| Western General Hospital /ID# 162612 | Edinburgh | EH4 2XU | United Kingdom |
| Queens Medical Centre /ID# 162615 | Nottinghamshire | NG7 2UH | United Kingdom |
| National Hospital of Tropical Diseases /ID# 167974 | Hanoi | 100000 | Vietnam |
| Hoa Hao Medic Co. Ltd. /ID# 168178 | Ho Chi Minh City | 700000 | Vietnam |
| Tropical Diseases Hospital /ID# 168211 | Ho Chi Minh City | 700000 | Vietnam |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: All participants who received at least one dose of study drug were included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | Per Protocol (PP) Population: All participants who received at least one dose of study drug, with the exception of participants who experienced breakthrough, or prematurely discontinued treatment prior to Week 8, or had no HCV RNA value in the SVR12 visit window or later. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI. | Intent to treat (ITT) population: Participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure. | PP population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment Virologic Failure in the ITT Population | On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks on treatment |
|
| ||||||||||||||||||||||||||
| 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 as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels < LLOQ at the end of treatment excluding participants who had been reinfected. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after the last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. | PP population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population | SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug |
|
|
Treatment emergent adverse events (TEAEs) were defined as any adverse event with an onset date that was on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
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 | Glecaprevir (GLE)/Pibrentasvir (PIB) | GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks. | 0 | 343 | 6 | 343 | 82 | 343 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
| |
| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 21.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2018 | Jun 24, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|