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This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.
This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.
This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.
After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.
This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hepatitis C Virus Genotype 1 (HCV + GT1) | ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] with or without dasabuvir [250 mg twice daily]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment | SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]). | 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic Response at End of Treatment (EoT) | Virologic response is defined as HCV RNA level <50 IU/mL. | Up to EoT, maximum of 24 weeks |
| Number of Participants Meeting Premature Study Drug Discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health). |
Inclusion Criteria:
Exclusion Criteria:
- None
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Participants with chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Cardioinfantil | Bogotá | Colombia | ||||
| Cic Cali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739368 | Derived | Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5. |
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A total of 66 participants were enrolled in the study; 1 participant never started treatment and thus the safety population was comprised of 65 participants. In this study, the safety population, target population, and core population were identical.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBVIE REGIMEN ± Ribavirin (RBV) | ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 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 | Mar 30, 2016 | Jul 22, 2019 |
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Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).
| Up to EoT, maximum of 24 weeks |
| Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria | For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:
Abbreviations: EoT=end of treatment. | During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks) |
| Percentage of Participants With Relapse | Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated. | 12 weeks (i.e. at least 70 days) after the last dose of study drug |
| Percentage of Participants With Relapse at EoT | Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window. | 12 weeks (i.e. at least 70 days) after the last dose of study drug |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | Up to EoT, maximum of 24 weeks |
| Percentage of Participants Meeting On-treatment Virologic Failure | On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL). | Up to EoT, maximum of 24 weeks |
| Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4) | RVR4 was defined as HCV RNA < 50 IU/mL at Week 4. | Week 4 |
| Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT | SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24. | 24 weeks after EoT (up to 24 weeks) |
| EoT (up to 24 weeks) |
| EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). | 12 weeks post EoT (up to 24 weeks) |
| EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). | 24 weeks post EoT (up to 24 weeks) |
| EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | End of Treatment (up to 24 weeks) |
| EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | 12 weeks post EoT (up to 24 weeks) |
| EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | 24 weeks post EoT (up to 24 weeks) |
| Number of Participants With Co-morbidities at Baseline (Day 0) | Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other). | Baseline (Day 0) |
| Number of Participants With Concomitant Medications | This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux. | Day 0 to EoT, maximum 24 weeks |
| Cali |
| 760001 |
| Colombia |
| Centro Medico lmbanaco de Cali I | Cali | Colombia |
| Pharos Centro de Estudios Clin | Cartagena | 130013 | Colombia |
| IPS Medicos Internistas Del Ca I | Manizales | 170004 | Colombia |
| Fundacion Hospitalaria San Vin | MedellÃn | 050010 | Colombia |
|
| COMPLETED |
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| NOT COMPLETED |
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|
The Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
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| ID | Title | Description |
|---|---|---|
| BG000 | ABBVIE REGIMEN ± Ribavirin (RBV) | ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 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 |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment | SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]). | Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks) |
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| Secondary | Percentage of Participants With Virologic Response at End of Treatment (EoT) | Virologic response is defined as HCV RNA level <50 IU/mL. | CP | Posted | Number | 95% Confidence Interval | percentage of participants | Up to EoT, maximum of 24 weeks |
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| Secondary | Number of Participants Meeting Premature Study Drug Discontinuation | Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]). | CP | Posted | Number | participants | Up to EoT, maximum of 24 weeks |
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| Secondary | Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria | For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:
Abbreviations: EoT=end of treatment. | CP | Posted | Number | percentage of participants | During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks) |
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| Secondary | Percentage of Participants With Relapse | Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated. | CP | Posted | Number | percentage of participants | 12 weeks (i.e. at least 70 days) after the last dose of study drug |
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| Secondary | Percentage of Participants With Relapse at EoT | Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window. | CP of participants with EoT response whose last post-treatment HCV RNA test result did not show virologic response | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks (i.e. at least 70 days) after the last dose of study drug |
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| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | CP | Posted | Number | 95% Confidence Interval | percentage of participants | Up to EoT, maximum of 24 weeks |
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| Secondary | Percentage of Participants Meeting On-treatment Virologic Failure | On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL). | CP | Posted | Number | percentage of participants | Up to EoT, maximum of 24 weeks |
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| Secondary | Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4) | RVR4 was defined as HCV RNA < 50 IU/mL at Week 4. | CP | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT | SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24. | CP participants with an SVR24 assessment | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after EoT (up to 24 weeks) |
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| Other Pre-specified | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health). | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | EoT (up to 24 weeks) |
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| Other Pre-specified | EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks post EoT (up to 24 weeks) |
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| Other Pre-specified | EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks post EoT (up to 24 weeks) |
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| Other Pre-specified | EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | End of Treatment (up to 24 weeks) |
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| Other Pre-specified | EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks post EoT (up to 24 weeks) |
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| Other Pre-specified | EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. | CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks post EoT (up to 24 weeks) |
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| Other Pre-specified | Number of Participants With Co-morbidities at Baseline (Day 0) | Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other). | CP | Posted | Number | participants | Baseline (Day 0) |
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| Other Pre-specified | Number of Participants With Concomitant Medications | This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux. | Safety Population: defined as all enrolled participants who received at least one dose of the ABBVIE REGIMEN | Posted | Number | participants | Day 0 to EoT, maximum 24 weeks |
|
|
Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug.
TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
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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 | ABBVIE REGIMEN | ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). | 0 | 49 | 5 | 49 | 5 | 49 |
| EG001 | ABBVIE REGIMEN Plus Ribavirin (RBV) | ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). | 0 | 16 | 2 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HEPATIC FIBROSIS | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| TREATMENT FAILURE | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| HEPATITIS C | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | Jul 22, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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