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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004876-23 | EudraCT Number |
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A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glecaprevir/Pibrentasvir | Experimental | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir | Drug | Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%. | 12 weeks after the last actual dose of study drug, Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in the Intention-to-Treat Population With SVR12 | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures. |
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Inclusion Criteria:
Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
Does not have current active hepatitis B virus infection defined as:
Platelets ≥ 150,000 cells/mm³
Albumin ≥ lower limit of normal (LLN)
Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
No past history/evidence of cirrhosis.
No history of hepatocellular carcinoma.
Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center /ID# 161261 | Birmingham | Alabama | 35215 | United States | ||
| Arkansas Gastroenterology /ID# 161266 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31646465 | Derived | Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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Participants were enrolled at 40 sites in Bulgaria, Canada, France, Germany, Poland, Russian Federation, Spain, United Kingdom, and the United States (including Puerto Rico).
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| ID | Title | Description |
|---|---|---|
| FG000 | Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2017 | Aug 5, 2019 |
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| 12 weeks after the last actual dose of study drug, Week 20 |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as one of the following conditions:
| Up to 8 weeks |
| 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 < LLOQ at the end of treatment. | From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20) |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| UC Davis Medical Center /ID# 161138 | Sacramento | California | 95817 | United States |
| Yale University /ID# 161258 | New Haven | Connecticut | 06510 | United States |
| Univ Maryland School Medicine /ID# 161157 | Baltimore | Maryland | 21201 | United States |
| Digestive Disease Associates - Baltimore /ID# 161260 | Baltimore | Maryland | 21229 | United States |
| University of Michigan Hospitals /ID# 161265 | Ann Arbor | Michigan | 48109-5008 | United States |
| Northwest Gastroenterology Cli /ID# 161257 | Portland | Oregon | 97210 | United States |
| Liver Associates of Texas, P.A /ID# 161262 | Houston | Texas | 77030-2783 | United States |
| University of Vermont Medical Center /ID# 161263 | Burlington | Vermont | 05401-1473 | United States |
| Digestive and Liver Disease Sp /ID# 161259 | Norfolk | Virginia | 23502 | United States |
| DCC Aleksandrovska /ID# 161340 | София | Sofia | 1431 | Bulgaria |
| DCC Mladost M /ID# 161339 | Varna | 9000 | Bulgaria |
| South Health Campus /ID# 161385 | Calgary | Alberta | T3M 1M4 | Canada |
| The Moncton Hospital /ID# 161384 | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Brampton Civic Hospital /ID# 161380 | Brampton | Ontario | L6R 3J7 | Canada |
| Toronto Liver Centre /ID# 161381 | Toronto | Ontario | M6H 3M1 | Canada |
| Hopital Saint Joseph /ID# 161571 | Marseille | Bouches-du-Rhone | 13285 | France |
| CHU de Rennes - PONTCHAILLOU /ID# 161492 | Rennes | Brittany Region | 35000 | France |
| CHU de Besancon - Jean Minjoz /ID# 161485 | Besançon | Doubs | 25000 | France |
| Hopitaux de Brabois Adultes /ID# 161482 | Vandœuvre-lès-Nancy | Lorraine | 54500 | France |
| Universitätsklinikum Frankfurt /ID# 161397 | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Charité Universitätsmedizin Campus Mitte /ID# 161395 | Berlin | 10117 | Germany |
| ICH Study Center GmbH & Co KG /ID# 161394 | Hamburg | 20146 | Germany |
| Centrum Badan Klinicznych /Id# 162218 | Wroclaw | Lower Silesian Voivodeship | 50-349 | Poland |
| HepID - Diagnostyka I Terapia /ID# 162219 | Lublin | Lublin Voivodeship | 20-884 | Poland |
| Uniwersytecki Szpital Kliniczn /ID# 162216 | Bialystok | 15-276 | Poland |
| ID Clinic /ID# 162217 | Mysłowice | 41-406 | Poland |
| Innovative Care P.S.C. /ID# 162787 | San Juan | 00959 | Puerto Rico |
| A. F. Agafonov Republican Clin /ID# 163164 | Kazan' | Tatarstan, Respublika | 420140 | Russia |
| South Ural State Medical univ /ID# 163163 | Chelyabinsk | 454052 | Russia |
| A.I. Evdokimov Moscow State Un /ID# 163162 | Moscow | 127473 | Russia |
| Hospital Fundacion Alcorcon /ID# 161436 | Alcorcón | 28922 | Spain |
| Hospital Clinic de Barcelona /ID# 161437 | Barcelona | 08036 | Spain |
| Hospital Vall d'Hebron /ID# 162022 | Barcelona | 8035 | Spain |
| Hosp Uni Virgen de la Victoria /ID# 164383 | Málaga | 29010 | Spain |
| Complexo Hospitalario universi /ID# 165603 | Pontevedra | 36071 | Spain |
| Bradford Teaching Hospitals /ID# 161424 | Bradford | BD9 6RJ | United Kingdom |
| Glasgow Royal Infirmary /ID# 161458 | Glasgow | G4 0SF | United Kingdom |
| Gloucester Royal Hospital /ID# 161423 | Gloucester | GL1 3NN | United Kingdom |
| Freeman Hospital /ID# 161459 | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food 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 | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Hepatitis C Virus (HCV) Genotype | Count of Participants | Participants |
| ||||||||||||||||||
| Aminotransferase/Platelet Ratio Index (APRI) | APRI is used to determine the likelihood of hepatic fibrosis and cirrhosis in patients with hepatitis C. APRI is calculated from the level of aspartate aminotransferase (AST) measured in a blood test (international units per liter [IU/L)] and platelet count (platelets/cubic millimeter) according to the following formula: APRI = [(AST/upper limit of the normal range (ULN) of AST) x 100] / Platelet count APRI scores of less than or equal to 1 have a good performance characteristic for excluding the presence of cirrhosis. | Median | Full Range | ratio |
| ||||||||||||||||
| HCV Ribonucleic Acid (RNA) Concentration | Median | Full Range | Log₁₀ IU/mL |
|
| 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 in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%. | The modified intention-to-treat (mITT) population includes all enrolled participants who received at least 1 dose of study drug, excluding participants who did not achieve SVR12 for reasons other than virologic failure, such as missing SVR12 data (5 participants) or premature study drug discontinuation (3 participants). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug, Week 20 |
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| Secondary | Percentage of Participants in the Intention-to-Treat Population With SVR12 | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures. | The intention-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug, Week 20 |
|
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as one of the following conditions:
| Intention-to-treat population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 8 weeks |
|
| ||||||||||||||||||||||||||
| 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 < LLOQ at the end of treatment. | Intention-to-treat population with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20) |
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From first dose of study drug through 30 days after the last dose of study drug; 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glecaprevir/Pibrentasvir | Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks. | 0 | 230 | 4 | 230 | 46 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| LIMB TRAUMATIC AMPUTATION | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 21.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2017 | Aug 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D006505 | Hepatitis |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
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| Unknown or Not Reported |
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| Asian |
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| Genotype 3 |
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| Genotype 4 |
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| Genotype 5 |
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| Genotype 6 |
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