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Completed

NCT Number: NCT02486406

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

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.

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Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cliniques Universitaires Saint-Luc /ID# 136910, Brussels, Brussels Capital, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ombitasvir/paritaprevir/ritonavir

Drug

Film-coated tablet for oral use

Other names: Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450, Ombitsvir/paritaprevir/ritonavir also known as Viekirax

Dasabuvir

Drug

Film-coated tablet for oral use

Other names: Exviera, ABT-333

Ribavirin

Drug

Film-coated tablet for oral use

Ombitasvir mini tablet

Drug

Film-coated tablet for oral use

Other names: ABT-267

Paritaprevir mini tablet

Drug

Film-coated tablet for oral use

Other names: ABT-450

Ritonavir mini tablet

Drug

Film-coated tablet for oral use

Dasabuvir mini tablet

Drug

Film-coated tablet for oral use

Other names: Exviera, ABT-333

Ribavirin solution

Drug

Oral solution

Primary outcomes

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

    Time frame: At Week 2

    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.

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

    Time frame: At Week 2

    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.

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

    Time frame: At Weeks 2 and 8

    Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

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

    Time frame: At Week 2

    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.

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

    Time frame: At Week 2

    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.

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

    Time frame: At Weeks 2 and 8

    Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

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

    Time frame: At Week 2

    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.

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

    Time frame: At Week 2

    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.

  9. Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)

    Time frame: At Weeks 2 and 8

    Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

  10. Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)

    Time frame: At Week 2

    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.

  11. Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)

    Time frame: At Week 2

    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.

  12. Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)

    Time frame: At Weeks 2 and 8

    Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

  13. Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)

    Time frame: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

    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.

Secondary outcomes

  1. 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

    Time frame: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

    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.

  2. 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

    Time frame: 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)

    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.

  3. 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

    Time frame: 12 or 24 weeks after starting study drug, depending on treatment duration

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)

Acronym: ZIRCON

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2015
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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