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This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 1, Arm A: DB 2-DAA | Experimental | Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis |
|
| Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA | Placebo Comparator | DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis |
|
| Substudy 2, Arm C: OL 2-DAA | Experimental | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | Tablet; ABT-450 coformulated with ritonavir and ABT-267 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment | The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group 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 active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. | 12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment | On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:
The 95% confidence interval was calculated using the Wilson's score method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nori Yachi | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26147154 | Result | Kumada H, Chayama K, Rodrigues L Jr, Suzuki F, Ikeda K, Toyoda H, Sato K, Karino Y, Matsuzaki Y, Kioka K, Setze C, Pilot-Matias T, Patwardhan M, Vilchez RA, Burroughs M, Redman R. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015 Oct;62(4):1037-46. doi: 10.1002/hep.27972. Epub 2015 Aug 25. | |
| 27084721 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Substudy 1, Arm A: DB 2-DAA | Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis |
| FG001 | Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
|
| Placebo | Drug | Tablet |
|
| up to 12 weeks |
| Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation | On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method. | up to 12 weeks |
| Percentage of Participants in the Active Treatment Group With Post-treatment Relapse | Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method. | within 12 weeks after last dose of study drug |
| Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation | Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method. | within 12 weeks after last dose of study drug |
| Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment | Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method. | 12 weeks after last dose of study drug |
| Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation | Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method. | 12 weeks after last dose of study drug |
| Derived |
| Gopalakrishnan S, Khatri A, Mensing S, Redman R, Menon R, Zha J. Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study. Adv Ther. 2016 Apr;33(4):670-83. doi: 10.1007/s12325-016-0320-y. Epub 2016 Mar 21. |
DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis |
| FG002 | Substudy 2, Arm C: OL 2-DAA | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Substudy 1, Arm A: DB 2-DAA | DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis |
| BG001 | Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA | DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis |
| BG002 | Substudy 2, Arm C: OL 2-DAA | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment | The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group 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 active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. | Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment | On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:
The 95% confidence interval was calculated using the Wilson's score method. | Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation). | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation | On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method. | ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A). | Posted | Number | 95% Confidence Interval | percentage of participants | up to 12 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Active Treatment Group With Post-treatment Relapse | Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method. | ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | within 12 weeks after last dose of study drug |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation | Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method. | ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation). | Posted | Number | 95% Confidence Interval | percentage of participants | within 12 weeks after last dose of study drug |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment | Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method. | ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation | Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method. | ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
AEs collected from time of informed consent through 30 days post-study drug dosing (dosing period was 12 or 24 weeks [12 weeks of placebo followed by 12 weeks of DAAs]); Serious AEs collected up to post-treatment Week 48.
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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 | Substudy 1, Arm A: DB 2-DAA | DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis. | 7 | 215 | 116 | 215 | ||
| EG001 | Substudy 1, Arm B: DB Placebo | DB placebo QD for 12 weeks in participants without cirrhosis | 2 | 106 | 48 | 106 | ||
| EG002 | Substudy 1, Arm B: OL 2-DAA | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis | 3 | 106 | 47 | 106 | ||
| EG003 | Substudy 2, Arm C: OL 2-DAA | OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis | 2 | 42 | 31 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NECROTISING RETINITIS | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| GASTRIC CANCER STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| RECTOSIGMOID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ANURIA | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| EYE DISCHARGE | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| GLOSSODYNIA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FEELING HOT | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| THIRST | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| ALPHA-2 MACROGLOBULIN INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| APOLIPOPROTEIN A-I DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMATOCRIT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| LYMPHOCYTE MORPHOLOGY ABNORMAL | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| SPUTUM RETENTION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ECZEMA ASTEATOTIC | Skin and subcutaneous tissue 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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| PRURITUS GENERALISED | 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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| HYPERTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPOTENSION | Vascular 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 Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| ≥ 65 years |
|
| Male |
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| Substudy 2, Arm C: OL 2-DAA |
OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis |
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