Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
NCT ID: NCT02249182
Last Updated: 2020-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2014-11-05
2018-08-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
LDV/SOF
LDV/SOF FDC administered orally once daily
RBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
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
LDV/SOF
LDV/SOF FDC administered orally once daily
RBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
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
LDV/SOF
LDV/SOF FDC administered orally once daily
RBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Interventions
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LDV/SOF
LDV/SOF FDC administered orally once daily
RBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection
* Screening laboratory values within defined thresholds
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Newcastle, New South Wales, Australia
Westmead, New South Wales, Australia
Parkville, Victoria, Australia
Auckland, , New Zealand
Birmingham, England, United Kingdom
Leeds, England, United Kingdom
London, England, United Kingdom
Glasgow, Scotland, United Kingdom
Countries
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References
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Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents. Hepatology 2015;62 (S1): 1040A-1041A
Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to < 12 Years Old. Hepatology 2016;64 (S1): 436A
Schwarz K, Murray KF, Rosenthal P, Bansal S, Lin CH, Ni L, et al. High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir. J Hepatol 2016; 64 (2): S184-S185
K.F. Murray, W. Balistreri, S. Bansal, S. Whitworth, H. Evans, R.P. Gonzalez-Peralta, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. J Hepatol 2017;66: S33-S62
Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.
Younossi ZM, Stepanova M, Balistreri W, Schwarz K, Murray KF, Rosenthal P, Bansal S, Hunt S. Health-related Quality of Life in Adolescent Patients With Hepatitis C Genotype 1 Treated With Sofosbuvir and Ledipasvir. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):112-116. doi: 10.1097/MPG.0000000000001754.
Begley R, Meng A, Massetto B, Shao J, Ling J, and Mathias A. Pharmacokinetics of Once Daily Sofosbuvir or Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 3 to <6 Years Old. Hepatology 2018;68 (S1): 582A.
Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to <6 Years Old with Chronic Hepatitis C Virus Infection. Hepatology 2018;68 (S1): 116A-117A.
Murray KF, Balistreri WF, Bansal S, Whitworth S, Evans HM, Gonzalez-Peralta RP, Wen J, Massetto B, Kersey K, Shao J, Garrison KL, Parhy B, Brainard DM, Arnon R, Gillis LA, Jonas MM, Lin CH, Narkewicz MR, Schwarz K, Rosenthal P. Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11. Hepatology. 2018 Dec;68(6):2158-2166. doi: 10.1002/hep.30123. Epub 2018 Nov 17.
Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, Mittal N, Massetto B, Brainard DM, Hsueh CH, Shao J, Parhy B, Narkewicz MR, Rao GS, Whitworth S, Bansal S, Balistreri WF. Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C. Hepatology. 2020 Feb;71(2):422-430. doi: 10.1002/hep.30830. Epub 2019 Aug 19.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Study Protocol: Amendment 5
Document Type: Study Protocol: Amendment 6
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-003578-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-337-1116
Identifier Type: -
Identifier Source: org_study_id
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