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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486406
Other study ID # M14-748
Secondary ID 2015-000111-41
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 28, 2015
Est. completion date November 19, 2020

Study information

Verified date September 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.


Description:

The study population for Part 1, the PK study, included GT1-infected participants who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or GT4-infected participants who were TN or interferon ([IFN] or Pegylated-interferon alfa-2a or 2b [pegIFN] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date November 19, 2020
Est. primary completion date November 19, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years to 17 Years
Eligibility Inclusion Criteria: 1. Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) = 1000 IU/mL at the time of screening 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: 1. Female participant who is pregnant, breastfeeding or is considering becoming pregnant 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc /ID# 136910 Brussels Bruxelles-Capitale
Belgium UZ Leuven /ID# 136911 Leuven
Germany Charite Universitaetsmedizin Berlin /ID# 141620 Berlin
Germany Universitaetsklinikum Freiburg /ID# 141618 Freiburg
Germany Helios Klinikum Wuppertal /ID# 142883 Wuppertal
Puerto Rico San Jorge Children Hospital /ID# 136832 San Juan
Spain Hospital Universitario Vall d'Hebron /ID# 137098 Barcelona
Spain Hospital Sant Joan de Deu /ID# 137096 Esplugues de Llobregat Barcelona
Spain Hospital Universitario La Paz /ID# 137094 Madrid
Spain Hospital Universitario y Politecnico La Fe /ID# 137097 Valencia
United States Children's Hospital Colorado /ID# 137017 Aurora Colorado
United States Boston Childrens Hospital /ID# 137174 Boston Massachusetts
United States Boston Medical Center /ID# 136831 Boston Massachusetts
United States University of Florida - Archer /ID# 136830 Gainesville Florida
United States Baylor College of Medicine /ID# 136590 Houston Texas
United States Indiana University /ID# 137015 Indianapolis Indiana
United States Columbia Univ Medical Center /ID# 136431 New York New York
United States Advent Health /ID# 167663 Orlando Florida
United States Children's Hospital of Philadelphia /ID# 137018 Philadelphia Pennsylvania
United States UCSF Benioff Childrens Hosp /ID# 136774 San Francisco California
United States Seattle Children's Hospital /ID# 137019 Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Puerto Rico,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV) Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. At Week 2
Primary Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV) AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing. At Week 2
Primary Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV) Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. At Weeks 2 and 8
Primary Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV) Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. At Week 2
Primary Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV) AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing. At Week 2
Primary Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV) Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. At Weeks 2 and 8
Primary Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV) Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. At Week 2
Primary Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV) AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. At Week 2
Primary Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV) Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. At Weeks 2 and 8
Primary Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV) Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. At Week 2
Primary Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV) AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing. At Week 2
Primary Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV) Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. At Weeks 2 and 8
Primary Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Secondary Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Secondary Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug. 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
Secondary Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations Alanine aminotransferase (ALT) normalization during treatment is defined as ALT = the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline. 12 or 24 weeks after starting study drug, depending on treatment duration
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