A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
NCT ID: NCT02486406
Last Updated: 2021-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2015-10-28
2020-11-19
Brief Summary
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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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Adult tablet, 12-17 yr, Part 1
Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
Ombitasvir/paritaprevir/ritonavir
Film-coated tablet for oral use
Dasabuvir
Film-coated tablet for oral use
Ribavirin
Film-coated tablet for oral use
Adult tablet, 12-17 yr, Part 2
Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
Ombitasvir/paritaprevir/ritonavir
Film-coated tablet for oral use
Dasabuvir
Film-coated tablet for oral use
Ribavirin
Film-coated tablet for oral use
Mini tablet, 9-11 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
Ombitasvir mini tablet
Film-coated tablet for oral use
Paritaprevir mini tablet
Film-coated tablet for oral use
Ritonavir mini tablet
Film-coated tablet for oral use
Dasabuvir mini tablet
Film-coated tablet for oral use
Ribavirin solution
Oral solution
Mini tablet, 3-8 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
Ombitasvir mini tablet
Film-coated tablet for oral use
Paritaprevir mini tablet
Film-coated tablet for oral use
Ritonavir mini tablet
Film-coated tablet for oral use
Dasabuvir mini tablet
Film-coated tablet for oral use
Ribavirin solution
Oral solution
Interventions
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Ombitasvir/paritaprevir/ritonavir
Film-coated tablet for oral use
Dasabuvir
Film-coated tablet for oral use
Ribavirin
Film-coated tablet for oral use
Ombitasvir mini tablet
Film-coated tablet for oral use
Paritaprevir mini tablet
Film-coated tablet for oral use
Ritonavir mini tablet
Film-coated tablet for oral use
Dasabuvir mini tablet
Film-coated tablet for oral use
Ribavirin solution
Oral solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
3. Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country
Exclusion Criteria
2. Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
3 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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UCSF Benioff Childrens Hosp /ID# 136774
San Francisco, California, United States
Children's Hospital Colorado /ID# 137017
Aurora, Colorado, United States
University of Florida - Archer /ID# 136830
Gainesville, Florida, United States
Advent Health /ID# 167663
Orlando, Florida, United States
Indiana University /ID# 137015
Indianapolis, Indiana, United States
Boston Childrens Hospital /ID# 137174
Boston, Massachusetts, United States
Boston Medical Center /ID# 136831
Boston, Massachusetts, United States
Columbia Univ Medical Center /ID# 136431
New York, New York, United States
Children's Hospital of Philadelphia /ID# 137018
Philadelphia, Pennsylvania, United States
Baylor College of Medicine /ID# 136590
Houston, Texas, United States
Seattle Children's Hospital /ID# 137019
Seattle, Washington, United States
Cliniques Universitaires Saint-Luc /ID# 136910
Brussels, Brussels Capital, Belgium
UZ Leuven /ID# 136911
Leuven, , Belgium
Charite Universitaetsmedizin Berlin /ID# 141620
Berlin, , Germany
Universitaetsklinikum Freiburg /ID# 141618
Freiburg im Breisgau, , Germany
Helios Klinikum Wuppertal /ID# 142883
Wuppertal, , Germany
San Jorge Children Hospital /ID# 136832
San Juan, , Puerto Rico
Hospital Sant Joan de Deu /ID# 137096
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron /ID# 137098
Barcelona, , Spain
Hospital Universitario La Paz /ID# 137094
Madrid, , Spain
Hospital Universitario y Politecnico La Fe /ID# 137097
Valencia, , Spain
Countries
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References
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Rosenthal P, Narkewicz MR, Yao BB, Jolley CD, Lobritto SJ, Wen J, Molleston JP, Hsu EK, Jonas MM, Zha J, Liu L, Leung DH. Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a. Adv Ther. 2020 Jul;37(7):3299-3310. doi: 10.1007/s12325-020-01389-9. Epub 2020 May 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-000111-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-748
Identifier Type: -
Identifier Source: org_study_id
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