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The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r and ABT-530 plus RBV | Experimental | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/ritonavir (r) | Drug | Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) | SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. | 12 weeks after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) | SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug. | 24 weeks after last dose of study drug |
| The Percentage of Subjects With Virologic Failure During Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armen Asatryan, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26778412 | Result | Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r and ABT-530 Plus RBV | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ABT-530 | Drug | Tablet |
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| Ribavirin (RBV) | Drug | Tablet |
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Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment. |
| Up to Treatment Week 12 |
| The Percentage of Subjects With Post-Treatment Relapse | Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment. | Within 12 weeks after the last dose of study drug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r and ABT-530 Plus RBV | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet |
| 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 | The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) | SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
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| Secondary | The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) | SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after last dose of study drug |
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| Secondary | The Percentage of Subjects With Virologic Failure During Treatment | Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Treatment Week 12 |
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| Secondary | The Percentage of Subjects With Post-Treatment Relapse | Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks after the last dose of study drug |
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Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs 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 | ABT-450/r and ABT-530 Plus RBV | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | 10 | 9 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| FAECES SOFT | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA 17.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 17.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 17.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 17.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
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| THIRST | General disorders | MedDRA 17.1 | Systematic Assessment |
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| ACARODERMATITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| ABNORMAL LOSS OF WEIGHT | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| BALANCE DISORDER | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.1 | 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 Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
|---|---|
| C585405 | paritaprevir |
| C000622691 | pibrentasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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