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The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-DAA ± RBV for 12 or 24 weeks | Experimental | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis. |
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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 [](streamdown:incomplete-link) | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic Failure During Treatment | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment. | up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3-DAA ± RBV for 12 or 24 Weeks | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ribavirin | Drug | Tablet |
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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 |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after the last actual dose of study drug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3-DAA ± RBV for 12 or 24 Weeks | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis. |
| 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 |
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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 [](streamdown:incomplete-link) | 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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| Secondary | Percentage of Participants With Virologic Failure During Treatment | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment. | Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group |
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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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| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual 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 for participants treated for 12 weeks and up to 28 weeks for participants treated for 24 weeks).
TEAEs and TESAEs are defined as any 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 | 3-DAA ± RBV for 12 or 24 Weeks | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis. | 7 | 99 | 58 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DRUG INTERACTION | General disorders | MedDRA (19.1) | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| DEPRESSIVE SYMPTOM | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal 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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| HAEMOGLOBIN DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue 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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| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| IRRITABILITY | 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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| PRURITUS | Skin and subcutaneous tissue 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 |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| D006526 | Hepatitis C |
| 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 |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| C000607373 | Viekira Pak |
| C585405 | paritaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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