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The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.
The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-267 (5 mg) once daily + pegIFN/RBV | Experimental | Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
| ABT-267 (50 mg) once daily + pegIFN/RBV | Experimental | Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
| ABT-267 (200 mg) once daily + pegIFN/RBV | Experimental | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
| Placebo + pegIFN/RBV | Placebo Comparator | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-267 | Drug | 5 mg or 25 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 4-week Rapid Virologic Response (RVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR. | Week 4 |
| Maximum Plasma Concentration (Cmax) of ABT-267 | Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) |
| Time to Maximum Plasma Concentration (Tmax) of ABT-267 | Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) |
| Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Early Virologic Response (pEVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armen Asatryan, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 56623 | Birmingham | Alabama | 35215 | United States | ||
| Site Reference ID/Investigator# 48476 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26597291 | Background | Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-267 (5 mg) Once Daily + pegIFN/RBV | Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pegylated interferon (pegIFN) | Drug | Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly |
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| Ribavirin (RBV) | Drug | 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day |
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| Placebo for ABT-267 | Other | Participants received matching placebo tablet at each dose level for ABT-267. |
|
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
| Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12 |
| Plasma Concentrations of Ribavirin (RBV) | Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range). | At each study visit from Week 1 to Week 12 |
| Serum Concentrations of Pegylated Interferon (pegIFN) | Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range). | At each study visit from Week 1 to Week 12 |
| Baseline and Week 12 |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR. | Week 12 |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12. | 12 weeks after the last dose of pegIFN/RBV |
| Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24. | 24 weeks after the last dose of pegIFN/RBV |
| Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days. | Approximately 12 weeks |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR. | Week 4 through Week 12 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Site Reference ID/Investigator# 51345 | Orlando | Florida | 32809 | United States |
| Site Reference ID/Investigator# 51498 | Honolulu | Hawaii | 96814 | United States |
| Site Reference ID/Investigator# 48473 | Indianapolis | Indiana | 46202 | United States |
| Site Reference ID/Investigator# 52782 | Kansas City | Missouri | 64131 | United States |
| Site Reference ID/Investigator# 48471 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 48474 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 48477 | Fairfax | Virginia | 22031 | United States |
| Site Reference ID/Investigator# 48472 | Seattle | Washington | 98101 | United States |
| Site Reference ID/Investigator# 48483 | San Juan | 00927 | Puerto Rico |
| FG001 |
| ABT-267 (50 mg) Once Daily + pegIFN/RBV |
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| FG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| FG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| Discontinued ABT-267 or Placebo |
|
| Discontinued pegIFN/RBV |
|
| COMPLETED |
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| NOT COMPLETED |
|
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All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-267 (5 mg) Once Daily + pegIFN/RBV | Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| BG001 | ABT-267 (50 mg) Once Daily + pegIFN/RBV | Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| BG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| BG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| BG004 | 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 |
| |||||||||||||||
| 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 4-week Rapid Virologic Response (RVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Partial Early Virologic Response (pEVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses. | Posted | Number | percentage of participants | Baseline and Week 12 |
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| Primary | Maximum Plasma Concentration (Cmax) of ABT-267 | Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | Mean | Standard Deviation | ng/mL | Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of ABT-267 | Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | Mean | Standard Deviation | Hours | Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267 | Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12 |
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| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses. | Posted | Number | percentage of participants | 12 weeks after the last dose of pegIFN/RBV |
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| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses. | Posted | Number | percentage of participants | 24 weeks after the last dose of pegIFN/RBV |
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| Secondary | Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses. | Posted | Median | 95% Confidence Interval | Days | Approximately 12 weeks |
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| Primary | Plasma Concentrations of Ribavirin (RBV) | Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range). | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | Median | Full Range | ng/mL | At each study visit from Week 1 to Week 12 |
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| Primary | Serum Concentrations of Pegylated Interferon (pegIFN) | Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range). | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | Median | Full Range | ng/mL | At each study visit from Week 1 to Week 12 |
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| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR. | All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses. | Posted | Number | percentage of participants | Week 4 through Week 12 |
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Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
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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-267 (5 mg) Once Daily + pegIFN/RBV | Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. | 0 | 9 | 9 | 9 | ||
| EG001 | ABT-267 (50 mg) Once Daily + pegIFN/RBV | Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. | 0 | 9 | 9 | 9 | ||
| EG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. | 0 | 10 | 8 | 10 | ||
| EG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. | 0 | 9 | 9 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| EAR DISCOMFORT | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
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| BLEPHARITIS | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| EYE INFLAMMATION | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| VISUAL IMPAIRMENT | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL TENDERNESS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| GLOSSITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| TONGUE DISORDER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 15.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 15.1 | Systematic Assessment |
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| FEELING ABNORMAL | General disorders | MedDRA 15.1 | Systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA 15.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 15.1 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 15.1 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 15.1 | Systematic Assessment |
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| NODULE | General disorders | MedDRA 15.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 15.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| TOOTH ABSCESS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPERAESTHESIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| PSYCHOMOTOR HYPERACTIVITY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| MOOD ALTERED | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| MOOD SWINGS | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| NIGHTMARE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| RESTLESSNESS | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
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| POSTMENOPAUSAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| HEAT RASH | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA 15.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C586094 | ombitasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms. | Regression, Logistic | Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors. | 0.171 | No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05. | 2-Sided | Superiority or Other |
| Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms. | Regression, Logistic | Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors. | 0.030 | No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05. | 2-Sided | Superiority or Other |
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
| OG002 |
| ABT-267 (200 mg) Once Daily + pegIFN/RBV |
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
| OG002 | ABT-267 (200 mg) Once Daily + pegIFN/RBV | Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
| OG003 | Placebo + pegIFN/RBV | Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. |
|
|
|