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This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind 3-DAA | Experimental | Double-blind 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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| Double-blind Placebo Followed by Open-label 3-DAA | Experimental | Double-blind placebo for 12 weeks, followed by open-label 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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| 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 active study drug |
| Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 24 weeks after the last actual dose of active study drug |
| 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 active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment. |
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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 |
|---|---|---|---|
| 29909549 | Derived | Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8. |
| Label | URL |
|---|---|
| Related Info. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind 3-DAA | Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
| FG001 | Double-blind Placebo Followed by Open-label 3-DAA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir | Drug | Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir |
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| up to 12 weeks |
| Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12 | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active 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 active study drug |
| Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24 | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | From the end of treatment through 24 weeks after the last dose of active study drug |
Double-blind placebo for 12 weeks, followed by open-label 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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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind 3-DAA | Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
| BG001 | Double-blind Placebo Followed by Open-label 3-DAA | Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice 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 |
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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) | All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of active study drug |
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| Primary | Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after the last actual dose of active study drug |
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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 active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment. | All participants who received at least 1 dose of active study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks |
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| Secondary | Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12 | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active 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 active 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 active study drug |
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| Secondary | Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24 | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active 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 active study drug, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 24 weeks after the last dose of active study drug |
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 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 3-DAA | Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. | 7 | 325 | 72 | 325 | ||
| EG001 | Double-blind Placebo | Double-blind placebo for 12 weeks. | 2 | 325 | 61 | 325 | ||
| EG002 | Open-label 3-DAA | Open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. | 5 | 324 | 55 | 324 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAL FISSURE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA (20.0) | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
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| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
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| VARICOSE VEIN | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (20.0) | 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 Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, 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 |
| D006521 | Hepatitis, Chronic |
| 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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| Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided >90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority). | percentage of participants | 100 | 2-Sided | 95 | 97.4 | 100.0 | Superiority | The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority. |
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