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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001022-14 | EudraCT Number |
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The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV) | Experimental | Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | Tablet for oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Death: Time to Event | Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| Liver-Related Death: Time to Event | Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| Liver Decompensation: Time to Event | Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FibroScan Score by SVR12 Status | The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis. |
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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 |
|---|---|---|---|---|---|---|
| CHU Bab El Oued /ID# 145420 | Algiers | 16000 | Algeria | |||
| CHU Bologhine Hospital /ID# 145421 |
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
For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks. |
| 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 | Jan 19, 2015 | Mar 11, 2022 |
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| ABT-333 | Drug | Tablet for oral use |
|
|
| Ribavirin (RBV) | Drug | Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose. |
|
| At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| Liver Transplantation: Time to Event | Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| Hepatocellular Carcinoma: Time to Event | Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event | Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945. | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260 |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures. | 12 weeks after the last actual dose of study drug |
| Algiers |
| 16000 |
| Algeria |
| CHU Mustapha Bacha /ID# 132130 | Algiers | 16000 | Algeria |
| St Vincent's Hospital Sydney /ID# 131001 | Darlinghurst | New South Wales | 2010 | Australia |
| Nepean Hospital /ID# 130999 | Kingswood | New South Wales | 2747 | Australia |
| Westmead Hospital /ID# 130997 | Westmead | New South Wales | 2145 | Australia |
| Greenslopes Private Hospital /ID# 131003 | Greenslopes | Queensland | 4120 | Australia |
| Royal Brisbane and Women's Hospital /ID# 131004 | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital /ID# 131002 | Adelaide | South Australia | 5000 | Australia |
| St Vincent's Hospital Melbourne /ID# 131000 | Fitzroy Melbourne | Victoria | 3065 | Australia |
| The Royal Melbourne Hospital /ID# 130998 | Parkville | Victoria | 3050 | Australia |
| Medizinische Universitaet Wien /ID# 131015 | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universitaet Graz /ID# 131018 | Graz | Styria | 8036 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 131017 | Linz | Upper Austria | 4010 | Austria |
| Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020 | Brussels | Brussels Capital | 1070 | Belgium |
| UCL Saint-Luc /ID# 131019 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 131021 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Tokuda Hospital Sofia /ID# 131022 | Sofia | 1407 | Bulgaria |
| UMHAT Sveti Ivan Rilski /ID# 131026 | Sofia | 1431 | Bulgaria |
| Univ Hosp for Active Treat /ID# 131023 | Sofia | 1527 | Bulgaria |
| Diagnostic Consultative Center /ID# 131027 | Sofia | 1612 | Bulgaria |
| UMHAT Sveta Marina /ID# 131025 | Varna | 9010 | Bulgaria |
| University of Calgary /ID# 134370 | Calgary | Alberta | T2N 4Z6 | Canada |
| GI Research & Associates /ID# 132169 | Edmonton | Alberta | T5H 4B9 | Canada |
| LAIR Centre /ID# 130970 | Vancouver | British Columbia | V5Z 1H3 | Canada |
| Vancouver Infectious Diseases Centre /ID# 134369 | Vancouver | British Columbia | V6Z 2C7 | Canada |
| GIRI Gastrointestinal Research Institute /ID# 132171 | Vancouver | British Columbia | V6Z 2K5 | Canada |
| University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969 | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Saint John Regional Hospital /ID# 131210 | Saint John | New Brunswick | E2L 4L2 | Canada |
| Ottawa Hospital Research Institute /ID# 132170 | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto General Hospital /ID# 132134 | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Liver Centre /ID# 132168 | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto Digestive Disease Asso /ID# 130968 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Clinique Medicale L'Actuel /ID# 132167 | Montreal | Quebec | H2L 4P9 | Canada |
| Jewish General Hospital /ID# 132165 | Montreal | Quebec | H3T 1E2 | Canada |
| Royal Victoria Hospital / McGill University Health Centre /ID# 132166 | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Quebec-Université Laval hôpital CHUL /ID# 132132 | Québec | Quebec | G1V 4G2 | Canada |
| Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031 | Hvidovre | Capital Region | 2650 | Denmark |
| Odense University Hospital /ID# 131029 | Odense C | Region Syddanmark | 5000 | Denmark |
| Aarhus Univ Hospital, Skejby /ID# 131030 | Aarhus | 8200 | Denmark |
| Helsinki University Hospital /ID# 131034 | Helsinki | Uusimaa | 00290 | Finland |
| Turku University Hospital /ID# 131032 | Turku | 20520 | Finland |
| Hopital Saint Joseph /ID# 132177 | Marseille | Bouches-du-Rhone | 13008 | France |
| CHU Limoges - Dupuytren 1 /ID# 131038 | Limoges | Franche-Comte | 87042 | France |
| Hopital Haut-Lévêque /ID# 131036 | Pessac | Gironde | 33604 | France |
| Hopital Saint Eloi /ID# 131037 | Montpellier | Herault | 34295 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 132179 | Nantes | Pays de la Loire Region | 44000 | France |
| Hopital Jean Verdier /ID# 135877 | Bondy | 93140 | France |
| CHU Grenoble - Hopital Michallon /ID# 131041 | La Tronche | 38700 | France |
| HCL - Hopital de la Croix-Rousse /ID# 131042 | Lyon | 69004 | France |
| Duplicate_Hopital lArchet 2 /ID# 131040 | Nice | 06202 | France |
| CHRU Pontchaillou /ID# 132173 | Rennes | 35033 | France |
| CHU Strasbourg - Hopital Civil /ID# 132174 | Strasbourg | 67091 | France |
| Hopital Universitaire Purpan Hopital Rangueil /ID# 131035 | Toulouse | 31059 | France |
| Universitaetsklinikum Freiburg /ID# 131044 | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsklinik Heidelberg /ID# 134371 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| LMU Klinikum der Universitat Muchen /ID# 131049 | Munich | Bavaria | 81377 | Germany |
| Universitaetsklinikum Frankfurt /ID# 131055 | Frankfurt am Main | Hesse | 60590 | Germany |
| Zentru fur HIV und Heaptogastroenterologie /ID# 131052 | Düsseldorf | North Rhine-Westphalia | 40237 | Germany |
| Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050 | Herne | North Rhine-Westphalia | 44623 | Germany |
| Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053 | Berlin | 13353 | Germany |
| Universitaetsklinikum Essen /ID# 131048 | Essen | 45147 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051 | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover /ID# 131054 | Hanover | 30625 | Germany |
| Centrum für interdisziplinaere Medizin /ID# 131046 | Münster | 48143 | Germany |
| General Hospital of Athens Ippokratio /ID# 131057 | Athens | Attica | 11527 | Greece |
| General Hospital of Athens Laiko /ID# 131088 | Athens | Attica | 11527 | Greece |
| General University Hospital of Alexandroupolis /ID# 131056 | Alexandroupoli | 68100 | Greece |
| Beaumont Hospital /ID# 131089 | Beaumont | Dublin | D09 XR63 | Ireland |
| St James Hospital /ID# 132180 | Dublin | Dublin | D08 NHY1 | Ireland |
| St Vincent's University Hospital /ID# 132181 | Elm Park | Dublin | D04 T6F4 | Ireland |
| The Chaim Sheba Medical Center /ID# 131092 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 132182 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus /ID# 131090 | Haifa | 3109601 | Israel |
| The Lady Davis Carmel Medical Center /ID# 131091 | Haifa | 34362 | Israel |
| Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095 | Bologna | Emilia-Romagna | 40138 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102 | Cona | Ferrara | 44124 | Italy |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190 | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Policlinico Agostino Gemelli /ID# 131098 | Rome | Lazio | 00168 | Italy |
| Ospedale San Raffaele IRCCS /ID# 131093 | Milan | Lombardy | 20132 | Italy |
| Fondazione PTV Policlinico Tor Vergata /ID# 132185 | Rome | Roma | 00133 | Italy |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188 | Bergamo | 24127 | Italy |
| Azienda Ospedaliero Universitaria Careggi /ID# 132197 | Florence | 50134 | Italy |
| Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195 | Foggia | 71122 | Italy |
| A.O.U. Policlinico G. Martino /ID# 132193 | Messina | 98125 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097 | Milan | 20122 | Italy |
| Ospedale S Giuseppe /ID# 132194 | Milan | 20123 | Italy |
| ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198 | Milan | 20142 | Italy |
| ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372 | Milan | 20157 | Italy |
| Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104 | Milan | 20162 | Italy |
| Azienda Ospedaliera Universitaria Federico II /ID# 131096 | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria Federico II /ID# 132191 | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184 | Palermo | 90127 | Italy |
| Azienda Ospedaliero-Universitaria di Parma /ID# 132183 | Parma | 43126 | Italy |
| Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192 | Salerno | 84131 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100 | Turin | 10126 | Italy |
| Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196 | Udine | 33100 | Italy |
| Hospital General de Tijuana /ID# 130972 | Tijuana | Estado de Baja California | 22680 | Mexico |
| Cife /Id# 130974 | Guadalajara | Jalisco | 44160 | Mexico |
| Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975 | Distrito Federal | 14000 | Mexico |
| CIF-BIOTEC/Medica Sur /ID# 134971 | Mexico City | 14050 | Mexico |
| ITESM campus Ciudad de Mexico /ID# 132383 | Mexico City | 14380 | Mexico |
| Instituto Metropolitano de Inv /ID# 132201 | Tlalpan | 14308 | Mexico |
| Erasmus Medisch Centrum /ID# 132206 | Rotterdam | South Holland | 3015 GD | Netherlands |
| Academisch Medisch Centrum /ID# 132205 | Amsterdam | 1105 AZ | Netherlands |
| Leids Universitair Medisch Centrum /ID# 132204 | Leiden | 2333 ZA | Netherlands |
| Akershus Universitetssykehus_MAIN /ID# 132212 | Lorenskog | Akershus | 1478 | Norway |
| St. Olavs Hospital HF /ID# 132213 | Trondheim | Sor-Trondelag | 7006 | Norway |
| Stavanger University Hospital /ID# 132211 | Stavanger | 4068 | Norway |
| Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-030 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115 | Lublin | Lublin Voivodeship | 20-081 | Poland |
| Wojewodzki Szpital Zakazny /ID# 131112 | Warsaw | Masovian Voivodeship | 01-201 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108 | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| ID Clinic /ID# 131111 | Mysłowice | Silesian Voivodeship | 41-406 | Poland |
| Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107 | Lodz | Łódź Voivodeship | 91-347 | Poland |
| Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119 | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116 | Lisbon | 1169-050 | Portugal |
| Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118 | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117 | Porto | 4099-001 | Portugal |
| Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120 | Sector 2 | Bucharest | 021105 | Romania |
| Institutul Clinic Fundeni /ID# 131121 | Sector 2 | Bucharest | 022328 | Romania |
| Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126 | Timișoara | Timiș County | 300310 | Romania |
| Institutul Nat. de Boli Infectioase /ID# 131124 | Bucharest | 010825 | Romania |
| SC Gastromedica SRL /ID# 131127 | Iași | 700506 | Romania |
| Medical Company Hepatolog /ID# 132277 | Samara | Samara Oblast | 443063 | Russia |
| Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270 | Kazan' | Tatarstan, Respublika | 420140 | Russia |
| South-Ural State Med. Academy /ID# 132274 | Chelyabinsk | 454052 | Russia |
| Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269 | Kemerovo | 650056 | Russia |
| Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278 | Krasnoyarsk | 660049 | Russia |
| Moscow Clinical Scientific Center n.a. Loginov /ID# 132266 | Moscow | 111123 | Russia |
| Central Clinical Hospital of Russian Academy of Science /ID# 132289 | Moscow | 117593 | Russia |
| I. M. Sechenov First Moscow State Medical University /ID# 132275 | Moscow | 119991 | Russia |
| City Clinical Hospital #24 /ID# 132268 | Moscow | 127015 | Russia |
| Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288 | Moscow | 129090 | Russia |
| Clinical Infectious Diseases Hospital #1 /ID# 132272 | Novosibirsk | 630099 | Russia |
| Samara State Medical University /ID# 136913 | Samara | 443099 | Russia |
| Stavropol State Medical University /ID# 132279 | Stavropol | 355017 | Russia |
| Tolyatti City Clinical Hospital #1 /ID# 132273 | Tolyatti | 445009 | Russia |
| Multidisciplinary Consultative and Diagnostic Center /ID# 131130 | Tyumen | 625026 | Russia |
| Sverdlovsk Regional Clinical Hospital #1 /ID# 132267 | Yekaterinburg | 620102 | Russia |
| King Abdulaziz Medical City /ID# 145129 | Jeddah | 21423 | Saudi Arabia |
| Ministry Nat Guard Hosp Health /ID# 145126 | Riyadh | 11426 | Saudi Arabia |
| King Khalid University Hospita /ID# 132291 | Riyadh | 11472 | Saudi Arabia |
| Hospital Universitari Son Espases /ID# 131140 | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Universitario Germans Trias i Pujol /ID# 132293 | Badalona | Barcelona | 08916 | Spain |
| Hospital Unversitario Marques de Valdecilla /ID# 131141 | Santander | Cantabria | 39008 | Spain |
| Hospital Donostia /ID# 131144 | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital General Universitario Santa Lucia /ID# 131139 | Cartagena | Murcia | 30202 | Spain |
| Hospital Universitario Central de Asturias /ID# 131138 | Oviedo | Principality of Asturias | 33011 | Spain |
| OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143 | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Universitario A Coruna - CHUAC /ID# 131137 | A Coruña | 15006 | Spain |
| Hospital Universitario Reina Sofia /ID# 131135 | Córdoba | 14004 | Spain |
| Hospital Universitario de la Princesa /ID# 131131 | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre /ID# 131133 | Madrid | 28041 | Spain |
| Hospital Universitario La Paz /ID# 131132 | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 131136 | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 131134 | Seville | 41013 | Spain |
| Hospital Clinico Universitario Lozano Blesa /ID# 132292 | Zaragoza | 50009 | Spain |
| Skane University hospital /ID# 131146 | Malmö | Skåne County | 214 28 | Sweden |
| Karolinska University Hospital Solna /ID# 131145 | Solna | Stockholm County | 171 64 | Sweden |
| Sahlgrenska University Hospital /ID# 131147 | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Kantonsspital St. Gallen /ID# 131148 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Universitätsspital Zürich /ID# 134881 | Zurich | Canton of Zurich | 8091 | Switzerland |
| Inselspital, Universitätsspital Bern /ID# 132294 | Bern | 3010 | Switzerland |
| Izmir Tepecik Training and Research Hospital /ID# 134968 | Konak | İzmir | 35180 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine /ID# 131150 | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Univ Medical Faculty /ID# 131151 | Ankara | 06590 | Turkey (Türkiye) |
| Uludag University Medical Faculty /ID# 132297 | Bursa | 16059 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty /ID# 131153 | Istanbul | 34093 | Turkey (Türkiye) |
| Ege University Medical Faculty /ID# 132298 | Izmir | 35040 | Turkey (Türkiye) |
| Karadeniz University /ID# 131152 | Trabzon | 61000 | Turkey (Türkiye) |
| Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306 | Poole | Dorset | BH15 2JB | United Kingdom |
| University Hospital Southampton NHS Foundation Trust /ID# 131161 | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Barts Health NHS Trust /ID# 132302 | London | London, City of | E1 2ES | United Kingdom |
| The Royal Free London NHS Foundation Trust /ID# 131159 | London | London, City of | NW3 2QG | United Kingdom |
| Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155 | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| NHS Greater Glasgow and Clyde /ID# 131162 | Glasgow | Scotland | G12 0XH | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust /ID# 131154 | Birmingham | B15 2TH | United Kingdom |
| Duplicate_NHS Tayside /ID# 132300 | Dundee | DD2 1UB | United Kingdom |
| NHS Lothian /ID# 134368 | Edinburgh | EH3 9HE | United Kingdom |
| Leeds Teaching Hospitals NHS Trust /ID# 132305 | Leeds | LS9 7TF | United Kingdom |
| King's College Hospital NHS Foundation Trusts /ID# 131157 | London | SE5 9RS | United Kingdom |
| University Hospital Plymouth NHS Trust /ID# 131160 | Plymouth | PL6 5FP | United Kingdom |
| Portsmouth Hospitals University NHS Trust /ID# 131158 | Portsmouth | PO6 3LY | United Kingdom |
| Northern Care Alliance NHS Group /ID# 131156 | Salford | M6 8HD | United Kingdom |
| St George's University Hospitals NHS Foundation Trust /ID# 132301 | Tooting | SW17 0QT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 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 |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| HCV Genotype 1 Subtype | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Prior HCV Treatment History | 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 | All-Cause Death: Time to Event | Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Liver-Related Death: Time to Event | Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Liver Decompensation: Time to Event | Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Liver Transplantation: Time to Event | Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Hepatocellular Carcinoma: Time to Event | Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event | Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945. | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | At Post-Treatment Weeks 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FibroScan Score by SVR12 Status | The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis. | ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data | Posted | Mean | Standard Deviation | kPa | At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures. | ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 203 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-423; TOPAZ-I) who received at least one dose of study drug
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 | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks. | 28 | 1,596 | 40 | 1,596 | 805 | 1,596 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DRUG INTERACTION | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATORENAL SYNDROME | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| DERMATITIS INFECTED | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| PANCREATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| TUMOUR THROMBOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PSYCHOMOTOR SKILLS IMPAIRED | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| AFFECT LABILITY | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANGER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SCHIZOAFFECTIVE DISORDER | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | 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 | Mar 22, 2017 | Mar 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C585405 | paritaprevir |
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
| GT1 Non-b without cirrhosis |
|
| GT1 Non-b with compensated cirrhosis |
|
| Missing |
|
| Kaplan-Meier estimate at PT Week 156 |
|
| Kaplan-Meier estimate at PT Week 208 |
|
| Kaplan-Meier estimate at PT Week 260 |
|
| Cox proportional hazards model |
| <0.001 |
| Cox Proportional Hazard Ratio |
| 0.126 |
| 2-Sided |
| 95 |
| 0.044 |
| 0.358 |
The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12. |
| Superiority |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
|
|
|
| OG001 |
| Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
|
|
|
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
|
|
|
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
|
|
|
| Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|