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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005280-32 | EudraCT Number |
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This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV | Experimental | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir, dasabuvir | Drug | tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With On-treatment Virologic Failure | Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment). |
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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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| Label | URL |
|---|---|
| Related info. | View source |
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A total 10 participants were enrolled in the first arm (ombitasvir/paritaprevir/r, dasabuvir, and SOF plus RBV for 6 weeks); based on inadequate efficacy in the first arm, subsequent arms (4 weeks of treatment; with or without RBV) were not enrolled per protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| sofosbuvir (SOF) | Drug | tablet |
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| ribavirin (RBV) | Drug | tablet |
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| 6 weeks |
| Percentage of Subjects With Post-treatment Relapse | Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment | Up to 12 weeks after last actual dose of active study drug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
| 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 |
| |||||||||||||||||
| 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 (SVR12) Post-treatment | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. | Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Subjects With On-treatment Virologic Failure | Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment). | ITT population | Posted | Number | percentage of participants | 6 weeks |
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| Secondary | Percentage of Subjects With Post-treatment Relapse | Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment | ITT population | Posted | Number | percentage of participants | Up to 12 weeks after last actual dose of active study drug |
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Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
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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 | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. | 1 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| PHYSICAL ASSAULT | Social circumstances | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR DISCOMFORT | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 18.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 18.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 18.0 | Systematic Assessment |
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| INFLAMMATION | General disorders | MedDRA 18.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| HAIR INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| MENTAL IMPAIRMENT | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| NEURALGIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| AGORAPHOBIA | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| NIGHTMARE | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| SKIN ATROPHY | Skin and subcutaneous tissue disorders | MedDRA 18.0 | 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 Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000607373 | Viekira Pak |
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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