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| ID | Type | Description | Link |
|---|---|---|---|
| HU15-01 | Other Identifier | Affiliate Study Tracker Number |
Not provided
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| Name | Class |
|---|---|
| IST GmbH, Germany | INDUSTRY |
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The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
• None
Not provided
Not provided
Chronic Hepatitis C (CHC)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
Not provided
| 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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This observational study was conducted in 14 medical centers in Hungary experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on November 27, 2015 and last patient last visit was on 23 May 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Virological Response 12 Weeks Post-treatment (SVR12) | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. | The Core population, defined as enrolled participants 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 after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
|
From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for12 or 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2015 | May 15, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | May 15, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) |
| Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. | End of treatment (week 12 or 24 depending on the treatment regimen) |
| Percentage of Participants With Relapse | Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. | End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. |
| Number of Participants With Breakthrough | Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | 12 or 24 weeks (depending on the treatment regimen) |
| Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | SVR12 non-response was categorized according to the following:
| 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
| Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir. | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
| Percentage of Participants With Adherence to Ribavirin by Adherence Category | Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
| Number of Participants Who Received Concomitant Medications | Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen) |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Presenteeism indicates the percentage of impairment while working due to health problems. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems. | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| Change From Baseline in Patient Activation Measure 13 (PAM-13) | PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health. | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
| Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) | Up to post treatment week 24 |
| Utilization of the AbbVie Patient Support Program (PSP) Components | At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:
| End of treatment (week 12 or 24 depending on the treatment regimen) |
| Satisfaction With the AbbVie Patient Support Program (PSP) Components | At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used. | End of treatment (weeks 12 or 24 depending on treatment regimen) |
| Other |
|
| Did Not Receive Treatment |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Years Since Diagnosis of HCV Infection | Mean | Standard Deviation | years |
|
| Hepatitis C Virus Genotype | Count of Participants | Participants |
|
| Cirrhosis Status | Count of Participants | Participants |
|
| Pretreatment Status | Count of Participants | Participants |
|
| HCV Ribonucleic Acid (RNA) Level | Mean | Standard Deviation | log10 IU/mL |
|
| Assigned Treatment | Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two (paritaprevir/ritonavir and ombitasvir) or three (paritaprevir/ritonavir, ombitasvir, and dasabuvir) direct-acting antiviral (DAA) drugs with or without ribavirin for 12 or 24 weeks. | Count of Participants | Participants |
|
| Co-morbidities | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who
| The Core population with sufficient follow-up data regarding SVR24 | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. | The Core population defined as enrolled participants 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 | End of treatment (week 12 or 24 depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants With Relapse | Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. | The Core population with VR at EOT, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. |
|
|
|
| Secondary | Number of Participants With Breakthrough | Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. | The Core population with at least one documented HCV RNA < 50 IU/mL while on treatment and at least one on-treatment or EOT measurement thereafter. | Posted | Count of Participants | Participants | 12 or 24 weeks (depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | SVR12 non-response was categorized according to the following:
| The Core population | Posted | Count of Participants | Participants | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir. | Core population | Posted | Number | percentage of participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
|
|
|
| Secondary | Percentage of Participants With Adherence to Ribavirin by Adherence Category | Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 | Core population who were prescribed ribavirin | Posted | Number | percentage of participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
|
| Secondary | Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | Core population who were prescribed ribavirin | Posted | Mean | Standard Deviation | percentage of days | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
|
|
|
| Secondary | Number of Participants Who Received Concomitant Medications | Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. | All treated participants | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
|
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | All treated participants | Posted | Count of Participants | Participants | From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen) |
|
|
|
| Secondary | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status. | Core population with available data at baseline and each time point. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status. | Core population with available data at baseline and each time point. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems. | The Core population who were employed and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Presenteeism indicates the percentage of impairment while working due to health problems. | The Core population who were employed and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems. | The Core population who were employed and with available data at baseline and each time point. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems. | The Core population with available data at baseline and each time point. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
|
| Secondary | Change From Baseline in Patient Activation Measure 13 (PAM-13) | PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health. | The Core population with available data at baseline and end of treatment. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
|
|
|
| Secondary | Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) | Core population | Posted | Count of Participants | Participants | Up to post treatment week 24 |
|
|
|
| Secondary | Utilization of the AbbVie Patient Support Program (PSP) Components | At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:
| Core population who participated in the PSP | Posted | Count of Participants | Participants | End of treatment (week 12 or 24 depending on the treatment regimen) |
|
|
|
| Secondary | Satisfaction With the AbbVie Patient Support Program (PSP) Components | At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used. | Core population who participated in the PSP with available data | Posted | Count of Participants | Participants | End of treatment (weeks 12 or 24 depending on treatment regimen) |
|
|
|
| 0 |
| 138 |
| 3 |
| 138 |
| 0 |
| 138 |
| EG001 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. | 3 | 105 | 4 | 105 | 16 | 105 |
| CARDIAC FAILURE | Cardiac disorders | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | Systematic Assessment |
|
| SEPSIS | Infections and infestations | Systematic Assessment |
|
| INTERVERTEBRAL DISC DISORDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HOSPITALISATION | Surgical and medical procedures | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | 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.
| 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 |
| Title | Measurements |
|---|---|
|
| Premature treatment discontinuation |
|
| None of the above criteria |
|
| Title | Measurements |
|---|---|
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| Title | Measurements |
|---|---|
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| Title | Measurements |
|---|---|
|
| Diuretics |
|
| Peptic ulcer / gastro-oesophageal reflux disease |
|
| Calcium channel blockers |
|
| Blood glucose-lowering drugs |
|
| Mineral supplements |
|
| Title | Measurements |
|---|---|
|
| 12 weeks after end of treatment |
|
|
| 24 weeks after end of treatment |
|
|
| 12 weeks after end of treatment |
|
|
| 24 weeks after end of treatment |
|
|
|
| 24 weeks after end of treatment |
|
|
|
| 24 weeks after end of treatment |
|
|
|
| 24 weeks after end of treatment |
|
|
|
| 24 weeks after end of treatment |
|
|
| Title | Measurements |
|---|---|
|
| Online educational material |
|
| Web-portal |
|
| App |
|
| None/missing |
|
| Satisfactory |
|
| Poor |
|
| Printed educational material |
|
|
| Online educational material |
|
|
| Web-portal |
|
|
| App |
|
|