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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02249182
Registration number
NCT02249182
Ethics application status
Date submitted
23/09/2014
Date registered
25/09/2014
Date last updated
2/03/2020
Titles & IDs
Public title
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
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Scientific title
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
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Secondary ID [1]
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2014-003578-17
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Secondary ID [2]
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GS-US-337-1116
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LDV/SOF
Treatment: Drugs - RBV
Experimental: 12 to < 18 Years Old - Participants between 12 to < 18 years of age weighing = 45 kg will receive LDV/SOF FDC (90/400 mg tablet or 4 x 22.5 mg/100 mg tablets or 8 x 11.25/50 mg granules based on swallowability assessment during screening).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV genotypes (GT) 1, 4, 5, or 6 treatment-naive (TN) with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 treatment-experienced (TE) without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
Experimental: 6 to < 12 Years Old - Participants between 6 to < 12 years of age weighing = 17 kg and < 45 kg will receive LDV/SOF FDC (45/200 mg as 2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules based on swallowability assessment during screening).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
Experimental: 3 to < 6 Years Old - Participants between 3 to < 6 years of age weighing = 17 kg will receive LDV/SOF FDC (45/200 mg granules as 4 x 11.25/50 mg packets) and participants weighing < 17 kg will receive LDV/SOF FDC (33.75/150 mg oral granules as 3 x 11.25/50 mg packets).
Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment.
United Kingdom:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks
United States/Australia/New Zealand:
HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks
HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks
HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks
HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
Treatment: Drugs: LDV/SOF
LDV/SOF FDC administered orally once daily
Treatment: Drugs: RBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
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Assessment method [1]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [1]
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Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10
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Primary outcome [2]
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [1]
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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
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Assessment method [1]
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Timepoint [1]
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Baseline; Weeks 1, 2, 4, 8, and 12
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Secondary outcome [2]
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
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Assessment method [2]
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Timepoint [2]
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Up to Day 10
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Secondary outcome [3]
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For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
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Assessment method [3]
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SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
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Timepoint [3]
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Posttreatment Week 4
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Secondary outcome [4]
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For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
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Assessment method [4]
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SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.
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Timepoint [4]
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Posttreatment Week 12
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Secondary outcome [5]
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For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
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Assessment method [5]
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SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
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Timepoint [5]
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Posttreatment Week 24
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Secondary outcome [6]
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For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
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Assessment method [6]
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Viral breakthrough was defined as having confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment.
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Timepoint [6]
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Up to 24 weeks
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Secondary outcome [7]
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For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
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Assessment method [7]
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Viral relapse was defined as having confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
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Timepoint [7]
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Up to Posttreatment Week 24
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Secondary outcome [8]
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For the Treatment Phase, Change From Baseline in HCV RNA
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Assessment method [8]
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Timepoint [8]
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Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
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Secondary outcome [9]
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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
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Assessment method [9]
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Timepoint [9]
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Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
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Secondary outcome [10]
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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
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Assessment method [10]
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ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT = ULN at each visit.
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Timepoint [10]
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Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
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Secondary outcome [11]
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For the Treatment Phase, Change From Baseline in Height
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Assessment method [11]
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Timepoint [11]
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Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
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Secondary outcome [12]
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For the Treatment Phase, Change From Baseline in Weight
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Assessment method [12]
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Timepoint [12]
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Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
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Secondary outcome [13]
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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Assessment method [13]
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Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
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Timepoint [13]
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Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
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Secondary outcome [14]
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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
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Assessment method [14]
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Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
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Timepoint [14]
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Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
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Secondary outcome [15]
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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Assessment method [15]
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Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
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Timepoint [15]
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Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
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Secondary outcome [16]
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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
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Assessment method [16]
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Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
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Timepoint [16]
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Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
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Secondary outcome [17]
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Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
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Assessment method [17]
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Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.
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Timepoint [17]
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Day 1
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Secondary outcome [18]
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Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
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Assessment method [18]
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Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40.
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Timepoint [18]
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Day 1
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Eligibility
Key inclusion criteria
Key
- Consent of parent or legal guardian required
- Chronic HCV infection
- Screening laboratory values within defined thresholds
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Minimum age
3
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of clinically significant illness or any other medical disorder that may
interfere with individual's treatment, assessment or compliance with the protocol.
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
- Pregnant or nursing females
- Known hypersensitivity to study medication
- Use of any prohibited concomitant medications as within 28 days of the Day 1 visit
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/08/2018
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Sample size
Target
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Newcastle
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Recruitment hospital [2]
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- Westmead
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Recruitment hospital [3]
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- Parkville
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Recruitment postcode(s) [1]
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- Newcastle
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Recruitment postcode(s) [2]
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- Westmead
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Recruitment postcode(s) [3]
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- Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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District of Columbia
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Country [5]
0
0
United States of America
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State/province [5]
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Georgia
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Country [6]
0
0
United States of America
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State/province [6]
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Indiana
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Country [7]
0
0
United States of America
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State/province [7]
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Kentucky
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Country [8]
0
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United States of America
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State/province [8]
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Maryland
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Country [9]
0
0
United States of America
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State/province [9]
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Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
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Missouri
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Country [11]
0
0
United States of America
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State/province [11]
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Nebraska
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Country [12]
0
0
United States of America
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State/province [12]
0
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New York
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Country [13]
0
0
United States of America
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State/province [13]
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North Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
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Ohio
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Pennsylvania
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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Country [17]
0
0
United States of America
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State/province [17]
0
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Texas
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Country [18]
0
0
United States of America
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State/province [18]
0
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Washington
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Country [19]
0
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United States of America
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State/province [19]
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West Virginia
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Country [20]
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New Zealand
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State/province [20]
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Auckland
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Country [21]
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United Kingdom
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State/province [21]
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England
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Country [22]
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United Kingdom
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State/province [22]
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Scotland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state
pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose
combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in
Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of
dosing of LDV/SOF FDC in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover
into the Treatment Phase with no interruption of study drug administration. The primary
objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and
tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants
with HCV.
During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to
swallow tablets.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02249182
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02249182
Download to PDF