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This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2.
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir/Pibrentasvir | Experimental | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period. Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. |
|
| Placebo / Glecaprevir/Pibrentasvir | Experimental | Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period. In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo tablet for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. | 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen. |
| Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. | 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen |
| Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug. | 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Arm A With On-treatment Virologic Failure | On-treatment virologic failure was defined as meeting one of the following:
|
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Inclusion Criteria:
Must be of Asian descent
Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU/ mL at Screening Visit.
Chronic HCV infection defined as one of the following:
HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon[pegIFN] with or without ribavirin, OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed ≥ 8 weeks prior to screening.
Participant must be documented as non-cirrhotic.
Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
Exclusion Criteria:
Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Peoples Hospit /ID# 156846 | Beijing | Beijing Municipality | 100044 | China | ||
| Guangzhou Eighth People's Hosp /ID# 156859 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32682494 | Derived | Wei L, Wang G, Alami NN, Xie W, Heo J, Xie Q, Zhang M, Kim YJ, Lim SG, Fredrick LM, Lu W, Liu W, Kalluri HV, Krishnan P, Tripathi R, Mobashery N, Burroughs M, Asatryan A, Jia J, Hou J. Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2). Lancet Gastroenterol Hepatol. 2020 Sep;5(9):839-849. doi: 10.1016/S2468-1253(20)30086-8. Epub 2020 Jul 16. |
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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.
Randomization was stratified by geographic region, genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). Participants were randomized to Arm A or Arm B in the following ratios: China: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3 - 6; South Korea and Singapore: 2:1 for GT1 and 2:1 for GT2.
This study was conducted at 47 sites in China, South Korea, and Singapore. Eligible participants were non-cirrhotic chronic hepatitis C (HCV) genotype (GT)1-6-infected adults with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period. Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2018 | Oct 16, 2019 |
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| Glecaprevir/Pibrentasvir |
| Drug |
Coformulated tablet for oral administration |
|
|
| 8 or 16 weeks depending on the treatment regimen |
| Percentage of Participants in Arm A With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection. | From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen). |
| Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. | 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen |
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| Guangdong General Hospital /ID# 156822 | Guangzhou | Guangdong | 510080 | China |
| Nanfang Hospital of Southern Medical University /ID# 156860 | Guangzhou | Guangdong | 510515 | China |
| The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900 | Guangzhou | Guangdong | 510630 | China |
| Xiangya Hospital Central South University /ID# 156901 | Changsha | Hunan | 410008 | China |
| The Second Hospital of Nanjing /ID# 156863 | Nanjing | Jiangsu | 210003 | China |
| Jiangsu Province People's Hospital /ID# 156861 | Nanjing | Jiangsu | 210029 | China |
| The First Hosp of Jilin Univ /ID# 156820 | Changchun | Jilin | 130021 | China |
| The Sixth People's Hospital of Shenyang /ID# 156849 | Shenyang | Liaoning | 110006 | China |
| Shanghai Changzheng Hospital /ID# 158072 | Shanghai | Shanghai Municipality | 200003 | China |
| Ruijin Hospital, Shanghai Jiaotong /ID# 157336 | Shanghai | Shanghai Municipality | 200025 | China |
| Huashan Hospital of Fudan University /ID# 156904 | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Public Health Cli Ctr /ID# 156832 | Shanghai | Shanghai Municipality | 201508 | China |
| West China Hospital /ID# 156830 | Chengdu | Sichuan | 610041 | China |
| Beijing Di Tan Hospital, Capital Medical University /ID# 156847 | Beijing | 100015 | China |
| 1st Hospital of Peking Uni /ID# 156845 | Beijing | 100034 | China |
| 302 Military Hospital Of China /ID# 156841 | Beijing | 100039 | China |
| Beijing Friendship Hospital /ID# 156840 | Beijing | 100050 | China |
| Beijing Youan Hosp, Cap Med Un /ID# 163430 | Beijing | 100069 | China |
| 1st Affiliated Hosp 3rd Milita /ID# 156831 | Chongqing | 400038 | China |
| Dalian Sixth Peoples Hospital /ID# 163433 | Dalian | 116031 | China |
| Mengchao Hepatobiliary Hospita /ID# 156902 | Fuzhou | 350025 | China |
| Hainan General Hospital /ID# 156839 | Haikou, Hainan | 570311 | China |
| Jinan Infectious Diseases Hosp /ID# 156886 | Jinan, Shandong | 250021 | China |
| Chinese People's Liberation Army 81 Hospital /ID# 156862 | Nanjing | 210002 | China |
| Shengjing Hospital of China Medical University /ID# 156824 | Shenyang | 110004 | China |
| Tianjin Third Central Hospital /ID# 156816 | Tianjin | 300170 | China |
| 1st Aff Hosp Xinjiang Med Uni /ID# 156887 | Ürümqi | 830054 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884 | Wuhan | 430022 | China |
| Tongji Hosp Tongji Med College /ID# 156885 | Wuhan | 430030 | China |
| Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765 | Xi'an | 710038 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432 | Xi'an | 710061 | China |
| Henan Provincial Peoples Hosp /ID# 157197 | Zhengzhou, Henan | 450000 | China |
| National University Hospital ( /ID# 163272 | Singapore | 119228 | Singapore |
| Singapore General Hospital /ID# 163271 | Singapore | 169608 | Singapore |
| Changi General Hospital /ID# 163270 | Singapore | 529889 | Singapore |
| Pusan National University Hosp /ID# 163371 | Busan | Busan Gwang Yeogsi | 602-739 | South Korea |
| Seoul National Univ Bundang ho /ID# 163367 | Seongnam | Gyeonggido | 13620 | South Korea |
| Inje University Busan Paik Hospital /ID# 163329 | Pusan | Gyeongsangbuk-do | 47392 | South Korea |
| Pusan Nat Univ Yangsan Hosp /ID# 163334 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Inha University Hospital /ID# 163320 | Junggu | Incheon Gwang Yeogsi | 22332 | South Korea |
| Yonsei University Health System, Severance Hospital /ID# 163339 | Seodaemun-gu | Seoul Teugbyeolsi | 03722 | South Korea |
| Samsung Medical Center /ID# 163364 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Cath Univ Seoul St Mary's Hosp /ID# 163341 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Korea Universtiy Guro Hospital /ID# 163380 | Seoul | Seoul Teugbyeolsi | 08308 | South Korea |
| Seoul National University Hospital /ID# 163348 | Seoul | 03080 | South Korea |
| Asan Medical Center /ID# 163336 | Seoul | 05505 | South Korea |
| FG001 |
| Arm B: Placebo / Glecaprevir/Pibrentasvir |
Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period. In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. |
| Received Double-blind Treatment |
|
| Completed Double-blind Period |
|
| Entered Open-label Period | The open-label treatment period was only applicable for participants assigned to Arm B (placebo). |
|
| Completed Open-label Period |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The safety population included all participants who received at least 1 dose of study drug during the DB Treatment Period
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period. |
| BG001 | Arm B: Placebo / Glecaprevir/Pibrentasvir | Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| HCV Genotype | Count of Participants | Participants |
| ||||||||||||||||
| Prior HCV Treatment History | Treatment-experienced includes treatment with interferon (IFN; alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN. | Count of Participants | Participants |
| |||||||||||||||
| Human Immunodeficiency Virus (HIV) Co-infection Status | Count of Participants | Participants |
| ||||||||||||||||
| HCV Ribonucleic Acid (RNA) Level | Mean | Standard Deviation | log₁₀ IU/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. | This endpoint was pre-specified to be analyzed in participants randomized to Arm A who received at least 1 dose of study drug during the DB Treatment Period. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen. |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. | This endpoint was pre-specified to be analyzed in GT1-infected participants randomized to Arm A who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. | Posted | Number | percentage of participants | 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug. | This endpoint was pre-specified to be analyzed in genotype 2-infected participants randomized to Arm A who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. | Posted | Number | percentage of participants | 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen. |
|
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| Secondary | Percentage of Participants in Arm A With On-treatment Virologic Failure | On-treatment virologic failure was defined as meeting one of the following:
| This endpoint was pre-specified to be analyzed in all participants randomized to Arm A who received at least 1 dose of study drug during the DB Treatment Period. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 or 16 weeks depending on the treatment regimen |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Arm A With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection. | This endpoint was pre-specified to be analyzed in all participants randomized to Arm A who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen). |
|
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| Secondary | Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12 | SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. | No HCV-HIV co-infected participants were enrolled in the study | Posted | 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen |
|
|
Double-blind Treatment Period: From initiation of study drug through 30 days after last dose and prior to Day 1 of the open-label period, if applicable; up to 12 or 20 weeks depending on the treatment regimen. Open-label Treatment Period (Arm B only): From the first dose of study drug in the OL period up to 30 days after the last dose of OL study drug; up to 12 or 20 weeks depending on the treatment regimen.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB Period: Arm A - Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period. Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. | 0 | 362 | 3 | 362 | 36 | 362 |
| EG001 | DB Period: Arm B - Placebo | Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period. Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. | 0 | 183 | 4 | 183 | 18 | 183 |
| EG002 | OL Period: Arm B - Glecaprevir/Pibrentasvir | Participants randomized to receive placebo in the DB treatment period received glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period. Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks. | 0 | 182 | 5 | 182 | 22 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 3, 2017 | Oct 16, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D000163 | Acquired Immunodeficiency Syndrome |
| D060085 | Coinfection |
| 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 |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
Not provided
Not provided
Not provided
| Male |
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| Singapore |
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| China |
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| Genotype 2 |
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| Genotype 3 |
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| Genotype 4 |
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| Genotype 5 |
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| Genotype 6 |
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| Treatment-experienced |
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| HCV / HIV co-infection |
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