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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001477-13 | EudraCT Number |
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The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: GT1B | Experimental | ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants |
|
| Group 2: GT1 Non-B | Experimental | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants |
|
| Group 3: GT4 | Experimental | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir | Drug | tablet; paritaprevir co-formulated with ritonavir and ombitasvir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 | SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method. | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR12 in Group 3 | SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Cohen, MD | AbbVie | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: GT1B | ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants |
| FG001 | Group 2: GT1 Non-B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| dasabuvir | Drug | tablet |
|
|
| ribavirin | Drug | tablet |
|
| 12 weeks after the last actual dose of study drug |
| Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure | On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. | Up to 24 weeks during treatment |
| Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12 | Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method. | Up to 12 weeks after the last actual dose of study drug |
| Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests | Improvement was defined as:
| Up to post-treatment Week 12 |
| Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest | The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12. | Up to post-treatment Week 12 |
| Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score | The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. | Up to post-treatment Week 12 |
| Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score | MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. | Up to post-treatment Week 12 |
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants |
| FG002 | Group 3: GT4 | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: GT1B | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants |
| BG001 | Group 2: GT1 Non-B | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants |
| BG002 | Group 3: GT4 | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
| BG003 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 | SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method. | Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR12 in Group 3 | SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. | Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure | On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. | Intent to treat population: all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks during treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12 | Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method. | Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after the last actual dose of study drug |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests | Improvement was defined as:
| Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter. | Posted | Number | percentage of participants | Up to post-treatment Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest | The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12. | Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12. | Posted | Number | percentage of participants | Up to post-treatment Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score | The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. | Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12. | Posted | Number | percentage of participants | Up to post-treatment Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score | MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. | Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12. | Posted | Number | percentage of participants | Up to post-treatment Week 12 |
|
Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
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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 | Group 1: GT1B | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants | 1 | 9 | 8 | 9 | ||
| EG001 | Group 2: GT1 Non-B | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants | 10 | 24 | 24 | 24 | ||
| EG002 | Group 3: GT4 | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
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| OCULAR ICTERUS | Hepatobiliary disorders | MedDRA version 19.1 | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| FUNGAL INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
| |
| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA version 19.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPERAESTHESIA | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPOTONIA | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| RADIAL NERVE PALSY | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| DEPRESSED MOOD | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| MOOD SWINGS | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| PANIC ATTACK | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
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| BREAST PAIN | Reproductive system and breast disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| EJACULATION FAILURE | Reproductive system and breast disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA version 19.1 | 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 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| >= 65 years |
|
| Male |
|
|
|
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
|
|
| OG002 | Group 3: GT4 | ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants |
|
|
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
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