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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000452-24 | EudraCT Number |
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This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
This was a Phase 2/3, multicenter study offered to participants who received at least one dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this study. The participant must have completed the follow-up period of the prior eligible AbbVie study. Participants were followed for a total of approximately 3 years after their last dose of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV-infected Participants | No Intervention | Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493 | Drug | ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen | Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study). | From the end of treatment in the previous study up to 3 years post-treatment |
| Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen | Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. | From the end of treatment in the previous study up to 3 years post-treatment |
| Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure | Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences. | From Day 1 to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death. |
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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 |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast /ID# 136725 | Dothan | Alabama | 36305 | United States | ||
| Felizarta /ID# 141033 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35220658 | Derived | Poordad F, Felizarta F, Yao BB, Overcash JS, Hassanein T, Agarwal K, Gane E, Shaw D, Waters M, Krishnan P, Topp A, Burroughs M, Nevens F. Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. Liver Int. 2022 Jun;42(6):1278-1286. doi: 10.1111/liv.15211. Epub 2022 Mar 14. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2/3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
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| ID | Title | Description |
|---|---|---|
| FG000 | HCV-infected Participants | Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study. |
| 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 | Oct 9, 2017 | Aug 31, 2020 |
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|
| ABT-530 | Drug | ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies. |
|
|
| After Day 1 up to 3 years post-treatment |
| Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease. | From Day 1 up to 3 years post-treatment |
| Mean FibroTest Score Over Time | A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis. | From Day 1 up to 3 years post-treatment |
| Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to ≥ 2.0, with scores < 0.5 predictive of no liver fibrosis; scores >1.5 significant fibrosis; and scores > 2.0 indicative of cirrhosis. | From Day 1 up to 3 years post-treatment |
| Mean FibroScan Scores Over Time | The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. 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. | Up to 3 years post-treatment |
| Bakersfield |
| California |
| 93301 |
| United States |
| Southern California Res. Ctr. /ID# 141799 | Coronado | California | 92118-1408 | United States |
| Research & Education, Inc. /ID# 169591 | San Diego | California | 92105 | United States |
| eStudySite San Diego /ID# 141040 | San Diego | California | 92120 | United States |
| eStudySite San Diego /ID# 141047 | San Diego | California | 92120 | United States |
| eStudySite San Diego /ID# 141048 | San Diego | California | 92120 | United States |
| Midway Immunology and Research /ID# 169477 | Ft. Pierce | Florida | 34982 | United States |
| Delta Research Partners /ID# 141028 | Bastrop | Louisiana | 71220 | United States |
| Louisiana Research Ctr. LLC /ID# 141024 | Shreveport | Louisiana | 71105-6800 | United States |
| Henry Ford Health System /ID# 141039 | Detroit | Michigan | 48202 | United States |
| Binghamton Gastroenterology /ID# 141026 | Binghamton | New York | 13903 | United States |
| Carolinas Center for Liver Dis /ID# 155390 | Statesville | North Carolina | 28677-3471 | United States |
| Northwest Gastroenterology Cli /ID# 141036 | Portland | Oregon | 97210 | United States |
| Gastro One /ID# 169478 | Germantown | Tennessee | 38138 | United States |
| Quality Medical Research, PLLC /ID# 141042 | Nashville | Tennessee | 37211 | United States |
| TX Clinical Research Institute /ID# 141037 | Arlington | Texas | 76012 | United States |
| Inquest Clinical Research /ID# 141045 | Baytown | Texas | 77521-2415 | United States |
| TX Liver Inst, Americ Res Corp /ID# 136727 | San Antonio | Texas | 78215 | United States |
| Bon Secours St. Mary's Hospita /ID# 165106 | Richmond | Virginia | 23226 | United States |
| St. Vincent's Hospital, Darlinghurst /ID# 155395 | Darlinghurst | New South Wales | 2010 | Australia |
| St. Vincents Hospital /ID# 155394 | East Lismore | New South Wales | 2480 | Australia |
| Westmead Hospital /ID# 155392 | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital /ID# 155396 | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital /ID# 155391 | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital /ID# 155393 | Parkville | Victoria | 3050 | Australia |
| Cliniques Universitaires Saint Luc /ID# 155397 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| CHU St. Pierre /ID# 155399 | Brussels | 1000 | Belgium |
| UZ Leuven /ID# 155398 | Leuven | 3000 | Belgium |
| University of Calgary /ID# 155400 | Calgary | Alberta | T2N 4Z6 | Canada |
| Toronto Liver Centre /ID# 155401 | Toronto | Ontario | M6H 3M1 | Canada |
| Universitätsklinikum Frankfurt /ID# 169817 | Frankfurt am Main | Hesse | 60590 | Germany |
| Mauss, Schmutz, Hegener, Athma /ID# 155402 | Düsseldorf | 40237 | Germany |
| Gastroenterologisch-Hepatologi /ID# 169820 | Kiel | 24146 | Germany |
| Auckland City Hospital /ID# 155403 | Auckland | 1023 | New Zealand |
| Gastro-Hepato & Geriatric Ctr /ID# 141060 | Ponce | 00716 | Puerto Rico |
| Klinical Investigations Group /ID# 141059 | San Juan | 00909 | Puerto Rico |
| Innovative Care P.S.C. /ID# 141061 | San Juan | 00959 | Puerto Rico |
| The Royal London Hospital /ID# 155405 | London | London, City of | E1 1BB | United Kingdom |
| King's College Hospital NHS /ID# 155406 | London | SE5 9RS | United Kingdom |
| St. Mary's Hospital /ID# 155404 | London | W2 1NY | United Kingdom |
| Derriford Hospital /ID# 155407 | Plymouth | PL6 8DH | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | HCV-infected Participants | Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study. The baseline data presented below are values at the time of the prior study start. |
| 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 | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Baseline Cirrhosis Status | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Treatment Status Prior to Previous Study | PRS= interferon (alpha, beta, or pegylated interferon) with or without ribavirin, or sofosbuvir with ribavirin with or without interferon]; NS5A= nonstructural viral protein 5A; PI= protease inhibitor | Count of Participants | Participants | No |
| |||||||||||||||||||||
| Baseline HIV-1/HCV coinfection status | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Baseline injection drug use status | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Baseline HCV RNA level | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| Study Drug Regimens Received in Prior Abbvie Study | 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 Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen | Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study). | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS. | Posted | Number | percentage of participants | From the end of treatment in the previous study up to 3 years post-treatment |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen | Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS. | Posted | Number | percentage of participants | From the end of treatment in the previous study up to 3 years post-treatment |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure | Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences. | Participants who experienced virologic failure in previous study or in the current study with available sequencing data for NS3/4A and/or NS5A | Posted | Number | participants | From Day 1 to Month 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection | Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS. | Posted | Count of Participants | Participants | No | After Day 1 up to 3 years post-treatment |
| |||||||||||||||||||||||||||
| Secondary | Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time | A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS. | Posted | Mean | Standard Deviation | ng/L | From Day 1 up to 3 years post-treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Mean FibroTest Score Over Time | A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS. | Posted | Mean | Standard Deviation | units on a scale | From Day 1 up to 3 years post-treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time | A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to ≥ 2.0, with scores < 0.5 predictive of no liver fibrosis; scores >1.5 significant fibrosis; and scores > 2.0 indicative of cirrhosis. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study. Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS. | Posted | Mean | Standard Deviation | ratio | From Day 1 up to 3 years post-treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Mean FibroScan Scores Over Time | The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. 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. | Full Analysis Set (FAS):all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-540 in a prior study were excluded from the FAS. | Posted | Mean | Standard Deviation | kPa | Up to 3 years post-treatment |
|
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Serious adverse events (SAEs) that the investigator considered reasonably related to interventional study procedures or those considered reasonably related to ABT-530 and/or ABT-493 exposure in the prior study by the investigator were collected from the time of the Day 1 visit of the current study period through the last study procedure or discontinuation from study, whichever was later, up to 3 years post-treatment.
An adverse event (AE) in this study is defined as any untoward medical occurrence in a patient or clinical investigation subject that occurs as a result of a study procedure, or is considered by the investigator to be reasonably related to exposure to ABT-493 and/or ABT-530 in the previous study. Deaths were collected as a medical event from the time of informed consent through study end. Serious adverse events outside of the study time frame and all nonserious adverse events were not collected.
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 | HCV-infected Participants-- FAS | Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2 /3 study and were not retreated prior to enrolling in this study. Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS. | 1 | 377 | 0 | 377 | 0 | 0 |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2019 | Aug 31, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
Not provided
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Not provided
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Multi race |
|
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| 4 |
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| 5 |
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| 6 |
|
| NS5A-experienced/PI naive |
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| NS5A- and PI- experienced |
|
| PI-experienced/NS5A naive |
|
| Missing |
|
| ABT-493 200 mg QD + ABT-530 80 mg QD-12 wks |
|
| ABT-493 200 mg QD + ABT-530 120 mg QD-12 wks |
|
| ABT-493 200 mg QD + ABT-530 120 mg QD + RBV-12 wks |
|
| ABT-493 300 mg QD + ABT-530 120 mg QD-8 wks |
|
| ABT-493 300 mg QD + ABT-530 120 mg QD-12 wks |
|
| ABT-493 300 mg QD + ABT-530 120 mg QD-16 wks |
|
| ABT-493 300 mg QD + ABT-530 120 mg QD + RBV-12 wks |
|
| ABT-493/ABT-530 300 mg/120 mg QD- 8 wks |
|
| ABT-493/ABT-530 300 mg/120 mg QD-12 wks |
|
| ABT-493/ABT-530 300 mg/120 mg QD-16 wks |
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