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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002035-29 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267, ABT-333 | Drug | Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After 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. | 12 weeks after the last actual dose of active study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period | Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. | At 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Enejosa, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24720679 | Result | Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10. | |
| 29377566 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-450/r/ABT-267 and ABT-333, Plus RBV | Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks |
| FG001 | Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV | Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Treatment |
|
| ||||||||||||||||||||||||
| Open-label Treatment |
|
Safety population: all randomized participants who received at least 1 dose of blinded study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-450/r/ABT-267 and ABT-333, Plus RBV | Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 After 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. | Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of active study drug |
|
Adverse events (AEs) were collected from the start of active study drug administration (double-blind [DB] or open-label [OL] active) to 30 days after the last dose of active study drug (total 16 weeks).
DB Placebo Arm: AEs collected from start of placebo until 30 days following discontinuation of placebo and prior to the OL period (if applicable; total 16 weeks). Serious AES collected from informed consent until the end of participation in the study (12 weeks, DB period; 12 weeks, OL period + 48-week post-treatment period; total up to 72 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 | Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV | Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C000607373 | Viekira Pak |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin | Drug | Capsule (double-blind treatment period), tablet (open-label treatment period) |
|
| Placebo for ABT-450/r/ABT-267 | Drug | Tablet |
|
| Placebo for ABT-333 | Drug | Tablet |
|
| Placebo for ribavirin | Drug | Capsule |
|
| Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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. | 12 weeks after the last actual dose of active study drug |
| Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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. | 12 weeks after the last actual dose of active study drug |
| Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm | Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. | 12 weeks after the last actual dose of active study drug |
| Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm | Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. | Within 12 weeks post-treatment |
| Derived |
| Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14. |
| Withdrawal by Subject |
|
| Other |
|
| NOT COMPLETED |
|
|
Double-blind placebo for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period | Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. | Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis. | Posted | Number | percentage of participants | At 12 weeks |
|
|
|
|
| Secondary | Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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. | Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of active study drug |
|
|
|
|
| Secondary | Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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. | Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of active study drug |
|
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm | Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. | Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of active study drug |
|
|
|
| Secondary | Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm | Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. | Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks post-treatment |
|
|
|
| 6 |
| 297 |
| 254 |
| 297 |
| EG001 | Double Blind Placebo | Double-blind placebo for 12 weeks | 1 | 97 | 74 | 97 |
| EG002 | Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV | Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks | 3 | 96 | 74 | 96 |
| BRADYCARDIA | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 16.0 | 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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |