CompletedPhase 2/3

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

United States64 participantsStarted 2015-10-28

Plain-language 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.

Who can participate

Age range3 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
✓. HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
✓. 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

✕. Female participant who is pregnant, breastfeeding or is considering becoming pregnant
✕. 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.
✕. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
✕. 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

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)

Timeframe: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)

Timeframe: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)

Timeframe: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)

Timeframe: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)

Trial details

NCT IDNCT02486406

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-19

Results submitted2021-09-07

View on ClinicalTrials.gov More Chronic Hepatitis C Infection trials

Plain-language summary

Who can participate

Age range3 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
✓. HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
✓. 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

✕. Female participant who is pregnant, breastfeeding or is considering becoming pregnant
✕. 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.
✕. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
✕. 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

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)

Timeframe: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)

Timeframe: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)

Timeframe: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)

Timeframe: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)

Timeframe: At Week 2

Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)