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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002012-33 | EudraCT Number |
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This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV GT1a (3-DAA) | Experimental | Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
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| HCV GT4 (2-DAA) | Experimental | Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir and dasabuvir | Drug | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | 12 weeks after the last actual dose of study drug |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section. | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291369 | Derived | Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5. |
| Label | URL |
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| Related Info | View source |
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This study included a 42-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | HCV GT1a (3-DAA) | Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
| FG001 | HCV GT4 (2-DAA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ombitasvir/paritaprevir/ritonavir | Drug | Tablet; ombitasvir coformulated with paritaprevir and ritonavir |
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| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | From the end of treatment through 12 weeks after the last dose of study drug |
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HCV GT1a (3-DAA) | Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
| BG001 | HCV GT4 (2-DAA) | Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| 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 With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\ | Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section. | Safety population: All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks) |
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 12 weeks after the last dose of study drug |
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
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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 | HCV GT1a (3-DAA) | Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. | 3 | 13 | 13 | 13 | ||
| EG001 | HCV GT4 (2-DAA) | Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. | 1 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| FOLLICULITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| END STAGE RENAL DISEASE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| CUSHING'S SYNDROME | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERPARATHYROIDISM | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| SALIVARY GLAND CALCULUS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Systematic Assessment |
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| PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| KIDNEY INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| TRANSAMINASES INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| BURNING SENSATION | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| SCIATICA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| EUPHORIC MOOD | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| C000607373 | Viekira Pak |
| C585405 | paritaprevir |
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| Male |
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| OG001 |
| HCV GT4 (2-DAA) |
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. |
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