Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004102-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years.
This was a multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of glecaprevir (GLE) and pibrentasvir (PIB) treatment for 8, 12, or 16 weeks in hepatitis C virus (HCV) genotype 1 - 6 (GT1 - GT6)-infected pediatric participants 3 to < 18 years of age, with or without compensated cirrhosis, with or without human immunodeficiency virus (HIV) coinfection, who are either treatment-naïve (TN), treatment-experienced (TE) with pegylated interferon (pegIFN) with or without ribavirin (RBV), or TE with sofosbuvir (SOF) + RBV with or without pegIFN.
The study was divided into 2 parts, according to the formulation of GLE/PIB administered. Part 1 of the study enrolled HCV GT1 - GT6 infected adolescent participants into the 12 to < 18 years old age group who were willing to swallow the adult formulation of GLE/PIB (Cohort 1). Part 2 of the study enrolled HCV GT1 - GT6 infected pediatric participants divided into the 9 to < 12 (Cohort 2), 6 to < 9 (Cohort 3), and 3 to < 6 (Cohort 4) years old age groups, to receive the pediatric formulation of GLE + PIB. Part 1 enrolled first and once the pediatric formulation was available enrollment into Part 2 commenced, with each cohort enrolled in parallel.
In each cohort, the first group of participants were enrolled into an intense pharmacokinetics (IPK) portion to characterize the PK and safety in each age group, followed by enrollment into a non-IPK safety/efficacy portion. Study participants enrolled in the IPK portion must have been HIV-negative, treatment-naive, and have an identified HCV genotype. In the IPK portion the first approximately six participants received an initial proposed dose of GLE and PIB based on the child's weight and age at screening. PK samples from these participants were evaluated to determine if therapeutic efficacious exposures were attained, comparable to those of adults, and if any dose adjustments were needed. After the intensive PK analysis results for the first six participants were available, enrollment of the remaining IPK portion resumed with subsequent participants receiving an adjusted final dose as applicable. Additional participants may have been required for further intensive PK analysis per age cohort if therapeutic exposure targets were not achieved.
Enrollment into the non-IPK safety and efficacy portions began when the dosing recommendations per age group based on the PK and clinical data from the IPK analysis were ascertained.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Adult Formulation; 12 to < 18 years | Experimental | Adolescents aged 12 to < 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/ 40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
| Cohort 2: Pediatric Formulation; 9 to < 12 years | Experimental | Children aged 9 to < 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 9 to < 12 years old (30 to < 45 kg) was GLE 200 mg + PIB 75 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 250 mg + PIB 100 mg. |
|
| Cohort 3: Pediatric Formulation; 6 to < 9 years | Experimental | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 6 to < 9 years old (20 to < 30 kg) was GLE 160 mg + PIB 60 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 200 mg + PIB 80 mg. |
|
| Cohort 4: Pediatric Formulation; 3 to < 6 years |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir Adult Formulation | Drug | Co-formulated film-coated tablet (100 mg/40 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir | The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of GLE was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis. | Week 2 from predose to 24 hours post-dose |
| Steady-state AUC0-24 of Pibrentasvir | The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of PIB was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis. | Week 2 from predose to 24 hours post-dose |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last actual dose of study drug. Plasma HCV RNA levels were collected using the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test v2.0. SVR12 was considered a primary efficacy endpoint by the United States (US) regulatory agency and was considered secondary outside of the US. | 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Glecaprevir | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. | Week 2 from predose to 24 hours post-dose |
| Apparent Clearance (CL/F) of Glecaprevir From Plasma |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of California San Francis /ID# 158002 | San Francisco | California | 94158 | United States | ||
| Childrens Hospital Colorado /ID# 157996 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42189498 | Derived | Thakre N, Beck D, Saeed AM, Eckert D, Chen MJ, Liu W, Lon HK, Mostafa NM, Mensing S. Population Pharmacokinetic Analysis of Glecaprevir and Pibrentasvir in Pediatric Patients >/= 3 to < 18 Years of Age with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection. Clin Pharmacokinet. 2026 May 26. doi: 10.1007/s40262-026-01637-1. Online ahead of print. | |
| 33811356 |
Not provided
Not provided
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
In each cohort participants were first enrolled into an intense pharmacokinetic (IPK) portion to characterize the PK and safety, followed by a non-IPK safety/efficacy part. PK samples from the first 6 participants in the IPK part were analyzed to determine the final dose used for the remaining IPK participants and in the non-IPK group.
A total of 129 participants were enrolled and 127 participants received at least 1 dose of study drug and were included in the intention-to-treat population.
Participants were enrolled at 38 sites in North America, Europe, and Japan. Cohort 1 enrolled adolescent participants aged 12 to < 18 years old. Subsequently, children aged 9 to < 12 (Cohort 2), 6 to < 9 (Cohort 3), and 3 to < 6 (Cohort 4) years old were enrolled in parallel.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 12 to < 18 Years | Adolescents aged 12 to < 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2019 | May 14, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 3 to < 6 years old (12 to < 20 kg) was GLE 120 mg + PIB 45 mg. After PK analysis from the first 5 enrolled participants the dose was adjusted to GLE 150 mg + PIB 60 mg. |
|
| Glecaprevir + Pibrentasvir Pediatric Formulation | Drug | Film-coated pellets/granules (15.67%/8.25%) administered by mixing with a small amount (1-2 teaspoons) of a soft food vehicle, such as hazelnut spread, Greek yogurt, or peanut butter. |
|
|
CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. |
| Week 2 from predose to 24 hours post-dose |
| Maximum Plasma Concentration of Pibrentasvir | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. | Week 2 from predose to 24 hours post-dose |
| Apparent Clearance of Pibrentasvir From Plasma | CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. | Week 2 from predose to 24 hours post-dose |
| Percentage of Participants Who Experienced On-treatment Virologic Failure | On-treatment virologic failure is defined as meeting one of the following:
| Up to Week 8, 12, or 16 (depending on treatment duration) |
| Percentage of Participants With Post-treatment Relapse up to 12 Weeks Post Treatment | Post-treatment relapse is defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment; excluding participants who had been shown to be re-infected. | Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
| Percentage of Participants With New Hepatitis C Virus Infection (Reinfection) | Reinfection is defined as confirmed HCV RNA ≥ 15 IU/mL in the post-treatment period in a participant who had HCV RNA < 15 IU/mL at the Final Treatment Visit, along with post-treatment detection of a different HCV genotype, subtype, or clade compared with Baseline, as determined by phylogenetic analysis of the nonstructural viral protein 3 (NS3) or NS5A, and/or NS5B gene sequences. | From the end of treatment up to post-treatment Week 144 |
| Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 1 "How Convenient or Inconvenient Was it to Prepare the Dose?" was answered as "very convenient", "convenient", "borderline", "inconvenient", or "very inconvenient". | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
| Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 2 "How Long Did it Typically Take for the Child to Take the Dose?" was answered as "5 minutes or less", "5 to 15 minutes", "15 to 30 minutes", or "more than 30 minutes". | Final treatment visit (up to Week 8, 12, or 16, depending on duration of treatment) |
| Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 3 "Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food?" was answered as "Yes" or "No". | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
| Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4 "Did You Experience Any Resistance When Feeding the Child the Medicine?" was answered as "Yes" or "No". | Final treatment visit (up to Week 8, 12, or 16 depending on treatment duration) |
| Palatability Questionnaire Question 4a: Type of Feeding Resistance | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4a "Type of feeding resistance?" tracks feeding resistance experienced at any time during treatment, and was answered as "Did not like taste of medicine", "Did not like texture of medicine", "Did not like the soft food used", "Did not like to swallow the amount of medicine", or "Unrelated to the medicine". | Up to final treatment visit (up to Week 8, 12, or 16 depending on treatment duration) |
| Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. Question 5 "How Easy or Difficult Was it for the Child to Swallow the Medicine?" was answered as "very easy", "easy", "borderline", "difficult", or "very difficult." | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| CT Childrens Medical Ctr, US /ID# 158639 | Hartford | Connecticut | 06106 | United States |
| UF Hepatology Research at CTRB /ID# 158008 | Gainesville | Florida | 32610-0272 | United States |
| Advent Health /ID# 166022 | Orlando | Florida | 32803 | United States |
| Indiana University /ID# 158001 | Indianapolis | Indiana | 46202 | United States |
| Boston Childrens Hospital /ID# 157988 | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center /ID# 157997 | Boston | Massachusetts | 02118 | United States |
| Columbia Univ Medical Center /ID# 158000 | New York | New York | 10032-3725 | United States |
| UNC Health Care /ID# 157991 | Chapel Hill | North Carolina | 27514 | United States |
| Cincinnati Childrens Hosp Med /ID# 158007 | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia /ID# 158003 | Philadelphia | Pennsylvania | 19104 | United States |
| Child Hosp of Pittsburgh,PA /ID# 158004 | Pittsburgh | Pennsylvania | 15213-2583 | United States |
| Monroe-Carell Jr. Children's H /ID# 169037 | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine /ID# 157989 | Houston | Texas | 77030-3411 | United States |
| Cliniques Universitaires Saint Luc /ID# 162173 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| UZ Leuven /ID# 162174 | Leuven | 3000 | Belgium |
| Alberta Children's Hospital /ID# 163449 | Calgary | Alberta | T3B 6A9 | Canada |
| Stollery Children's Hospital /ID# 163450 | Edmonton | Alberta | T6G 2X8 | Canada |
| Hospital for Sick Children /ID# 163448 | Toronto | Ontario | M5G 1X8 | Canada |
| Universitatsklinikum Freiburg /ID# 165187 | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Charite Universitaetsmedizin Berlin /ID# 165186 | Berlin | 10117 | Germany |
| Helios Klinikum Wuppertal /ID# 165185 | Wuppertal | 42283 | Germany |
| Kurume University Hospital /ID# 165718 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Osaka General Medical Center /ID# 212745 | Osaka | Osaka | 558-8558 | Japan |
| Osaka University Hospital /ID# 165709 | Suita-shi | Osaka | 565-0871 | Japan |
| Juntendo University Hospital /ID# 212912 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| San Jorge Children Hospital /ID# 160850 | San Juan | 00912-3310 | Puerto Rico |
| Federal State Budgetary Institution - Institute of Nutrition /ID# 163345 | Moscow | Moscow | 109240 | Russia |
| National Medical Scientific Centre of children health /ID# 163344 | Moscow | Moscow | 119296 | Russia |
| Scientific and Research Institute of pediatric infections /ID# 163343 | Saint Petersburg | 197022 | Russia |
| Hospital Sant Joan de Deu /ID# 163282 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 163323 | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz /ID# 163283 | Madrid | 28046 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 163325 | Valencia | 46026 | Spain |
| Birmingham Childrens Hospital /ID# 162718 | Birmingham | B4 6NH | United Kingdom |
| Queen Elizabeth University Hos /ID# 162719 | Glasgow | G514TF | United Kingdom |
| King's College Hospital NHS /ID# 162717 | London | SE5 9RS | United Kingdom |
| Jonas MM, Rhee S, Kelly DA, Del Valle-Segarra A, Feiterna-Sperling C, Gilmour S, Gonzalez-Peralta RP, Hierro L, Leung DH, Ling SC, Lobzin Y, Lobritto S, Mizuochi T, Narkewicz MR, Sabharwal V, Wen J, Kei Lon H, Marcinak J, Topp A, Tripathi R, Sokal E. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study. Hepatology. 2021 Jul;74(1):19-27. doi: 10.1002/hep.31841. |
| 31254392 | Derived | Jonas MM, Squires RH, Rhee SM, Lin CW, Bessho K, Feiterna-Sperling C, Hierro L, Kelly D, Ling SC, Strokova T, Del Valle-Segarra A, Lovell S, Liu W, Ng TI, Porcalla A, Gonzalez YS, Burroughs M, Sokal E. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. Hepatology. 2020 Feb;71(2):456-462. doi: 10.1002/hep.30840. Epub 2019 Aug 13. |
| FG001 |
| Cohort 2: 9 to < 12 Years |
Children aged 9 to < 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to < 45 kg was GLE 250 mg + PIB 100 mg. |
| FG002 | Cohort 3: 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| FG003 | Cohort 4: 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| Intense Pharmacokinetic Portion | Includes participants who provided IPK samples by age group |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat (ITT) population: all participants who received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years | Adolescents aged 12 to < 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience. |
| BG001 | Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years | Children aged 9 to < 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to < 45 kg was GLE 250 mg + PIB 100 mg. |
| BG002 | Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| BG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Baseline Fibrosis Stage | Fibrosis stage was determined by biopsy score, FibroScan score (if biopsy not available), or FibroTest score (if biopsy and FibroScan not available) and is equivalent to the liver biopsy Metavir score: F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with few septa; F3: numerous septa without cirrhosis; F4: cirrhosis. | Count of Participants | Participants | No |
| ||||||||||||||
| Hepatitis C Virus Genotype | Count of Participants | Participants |
| ||||||||||||||||
| Prior HCV Treatment History | Count of Participants | Participants |
| ||||||||||||||||
| Co-infection with Human Immunodeficiency Virus (HIV) | Count of Participants | Participants | No |
| |||||||||||||||
| HCV Ribonucleic Acid (RNA) Level | HCV RNA quantified by Roche COBAS Ampliprep/COBAS TaqMan HCV Quantitative Test, version 2.0. | 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 | Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir | The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of GLE was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) is summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | ng*h/mL | Week 2 from predose to 24 hours post-dose |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Steady-state AUC0-24 of Pibrentasvir | The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of PIB was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | ng*h/mL | Week 2 from predose to 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last actual dose of study drug. Plasma HCV RNA levels were collected using the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test v2.0. SVR12 was considered a primary efficacy endpoint by the United States (US) regulatory agency and was considered secondary outside of the US. | Intention-to-treat population: all participants who received at least 1 dose of study drug; Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backwards imputation were counted as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Glecaprevir | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Week 2 from predose to 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance (CL/F) of Glecaprevir From Plasma | CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | L/h | Week 2 from predose to 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of Pibrentasvir | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Week 2 from predose to 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance of Pibrentasvir From Plasma | CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. | Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received. | Posted | Geometric Mean | 95% Confidence Interval | L/h | Week 2 from predose to 24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced On-treatment Virologic Failure | On-treatment virologic failure is defined as meeting one of the following:
| Intention-to-treat population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Week 8, 12, or 16 (depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Post-treatment Relapse up to 12 Weeks Post Treatment | Post-treatment relapse is defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment; excluding participants who had been shown to be re-infected. | Participants in the ITT population who completed treatment (based on study drug duration) with HCV RNA < 15 IU/mL at the final treatment visit and with at least one post-treatment HCV RNA value. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With New Hepatitis C Virus Infection (Reinfection) | Reinfection is defined as confirmed HCV RNA ≥ 15 IU/mL in the post-treatment period in a participant who had HCV RNA < 15 IU/mL at the Final Treatment Visit, along with post-treatment detection of a different HCV genotype, subtype, or clade compared with Baseline, as determined by phylogenetic analysis of the nonstructural viral protein 3 (NS3) or NS5A, and/or NS5B gene sequences. | Intention-to-treat population | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment up to post-treatment Week 144 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 1 "How Convenient or Inconvenient Was it to Prepare the Dose?" was answered as "very convenient", "convenient", "borderline", "inconvenient", or "very inconvenient". | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 2 "How Long Did it Typically Take for the Child to Take the Dose?" was answered as "5 minutes or less", "5 to 15 minutes", "15 to 30 minutes", or "more than 30 minutes". | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Final treatment visit (up to Week 8, 12, or 16, depending on duration of treatment) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 3 "Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food?" was answered as "Yes" or "No". | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4 "Did You Experience Any Resistance When Feeding the Child the Medicine?" was answered as "Yes" or "No". | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Final treatment visit (up to Week 8, 12, or 16 depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 4a: Type of Feeding Resistance | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4a "Type of feeding resistance?" tracks feeding resistance experienced at any time during treatment, and was answered as "Did not like taste of medicine", "Did not like texture of medicine", "Did not like the soft food used", "Did not like to swallow the amount of medicine", or "Unrelated to the medicine". | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Up to final treatment visit (up to Week 8, 12, or 16 depending on treatment duration) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine? | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. Question 5 "How Easy or Difficult Was it for the Child to Swallow the Medicine?" was answered as "very easy", "easy", "borderline", "difficult", or "very difficult." | Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit | Posted | Count of Participants | Participants | No | Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration) |
|
Adverse events are reported from first dose of study drug up to 30 days after last dose (up to 20 weeks depending on the duration of treatment). Deaths are reported through Post Treatment Week 144.
Not provided
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 | Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years | Adolescents aged 12 to < 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. | 0 | 47 | 0 | 47 | 31 | 47 |
| EG001 | Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years | Children aged 9 to < 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to < 45 kg was GLE 250 mg + PIB 100 mg. | 0 | 29 | 0 | 29 | 15 | 29 |
| EG002 | Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. | 0 | 27 | 0 | 27 | 16 | 27 |
| EG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. | 0 | 24 | 0 | 24 | 17 | 24 |
| EG004 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. | 0 | 80 | 0 | 80 | 48 | 80 |
| EG005 | Total | Participants in Cohorts 1 to 4. | 0 | 127 | 0 | 127 | 79 | 127 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| MOTION SICKNESS | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| LICE INFESTATION | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (25.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2018 | May 14, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000654128 | glecaprevir and pibrentasvir |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Multiple |
|
| F2 |
|
| F3 |
|
| F4 |
|
| Genotype 2 |
|
| Genotype 3 |
|
| Genotype 4 |
|
| Genotype 5 |
|
| Genotype 6 |
|
| Experienced |
|
| No |
|
| OG002 | Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg. |
|
|
| OG002 | Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG004 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
| OG005 | Total | Participants in Cohorts 1 to 4. |
|
|
| OG002 |
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg. |
|
|
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg. |
|
|
| OG002 |
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg. |
|
|
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg. |
|
|
| OG002 |
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG004 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
| OG005 | Total | Participants in Cohorts 1 to 4. |
|
|
| OG002 | Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years | Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG004 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
| OG005 | Total | Participants in Cohorts 1 to 4. |
|
|
| OG002 |
| Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years |
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening. |
| OG003 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG004 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
| OG005 | Total | Participants in Cohorts 1 to 4. |
|
|
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to < 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening.
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|
| OG002 | Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years | Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to < 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening. |
| OG003 | Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years | Children aged 3 to < 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to < 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to < 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to < 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. |
|
|