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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002087-17 | EudraCT Number |
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This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-493/ABT-530 for 12 weeks | Experimental | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
|
| ABT-493/ABT-530 for 8 weeks | Experimental | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493/ABT-530 | Drug | Tablet; ABT-493 coformulated with ABT-530 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm | 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 study drug |
| Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after last actual dose of study drug |
| Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after last actual dose of study drug |
| Percentage of Participants With SVR12 |
Not provided
Inclusion Criteria:
Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:
OR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29365309 | Background | Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourliere M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417. | |
| 31568620 |
| Label | URL |
|---|---|
| Related Info | View source |
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This study included a 35-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-493/ABT-530 for 12 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| FG001 | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug (ITT population).
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-493/ABT-530 for 12 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| BG001 | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset or worsening date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-493/ABT-530 for 12 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
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| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
| C000654128 | glecaprevir and pibrentasvir |
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SVR12 was defined as plasma HCV RNA level \ |
| 12 weeks after last actual dose of study drug |
| Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after last actual dose of study drug |
| Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after last actual dose of study drug |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \ | Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment |
| Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants | On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \ | Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment |
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \ | From the end of treatment through 12 weeks after the last dose of study drug |
| Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants | Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \ | From the end of treatment through 12 weeks after the last dose of study drug |
| Derived |
| Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18. |
| 30977945 | Derived | Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20. |
| 30923816 | Derived | Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022. |
| 30868245 | Derived | Naganuma A, Chayama K, Notsumata K, Gane E, Foster GR, Wyles D, Kwo P, Crown E, Bhagat A, Mensa FJ, Otani T, Larsen L, Burroughs M, Kumada H. Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. J Gastroenterol. 2019 Aug;54(8):752-761. doi: 10.1007/s00535-019-01569-7. Epub 2019 Mar 13. |
| 30529905 | Derived | Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24. |
| 30012435 | Derived | Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10. |
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| ABT-493/ABT-530 for 12 Weeks |
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
|
|
|
| Primary | Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last actual dose of study drug |
|
|
|
|
| Primary | Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
|
|
|
| Secondary | Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With SVR12 | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants | SVR12 was defined as plasma HCV RNA level \ | All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \ | All participants who received at least 1 dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of particpants | Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment |
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants | On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \ | All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve. | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment |
|
|
|
| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \ | All participants who received at least 1 dose of 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 study drug |
|
|
|
| Secondary | Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants | Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \ | All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve, received at least 1 dose of 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 study drug |
|
|
|
| 4 |
| 352 |
| 130 |
| 352 |
| EG001 | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks. | 5 | 351 | 133 | 351 |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| ARTERIAL INJURY | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| 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 |