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Chronic Hepatitis C InfectionPhase 2/3ZIRCONNCT02486406

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

A Phase 2/3 study testing Ombitasvir/paritaprevir/ritonavir, Dasabuvir and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
Ombitasvir/paritaprevir/ritonavir, Dasabuvir and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
21 sitesin 5 countries
Study dates
28 Oct 2015to 19 Nov 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States11 sites

  • Children's Hospital Colorado /ID# 137017

    Aurora, Colorado, 80045

  • Boston Childrens Hospital /ID# 137174

    Boston, Massachusetts, 02115

  • Boston Medical Center /ID# 136831

    Boston, Massachusetts, 02118

  • University of Florida - Archer /ID# 136830

    Gainesville, Florida, 32610

  • Baylor College of Medicine /ID# 136590

    Houston, Texas, 77030-3411

  • Indiana University /ID# 137015

    Indianapolis, Indiana, 46202

  • Columbia Univ Medical Center /ID# 136431

    New York, New York, 10032-3725

  • Advent Health /ID# 167663

    Orlando, Florida, 32803

  • Children's Hospital of Philadelphia /ID# 137018

    Philadelphia, Pennsylvania, 19104

  • UCSF Benioff Childrens Hosp /ID# 136774

    San Francisco, California, 94158

  • Seattle Children's Hospital /ID# 137019

    Seattle, Washington, 98105

Other trials in United States

Spain4 sites

  • Hospital Universitario Vall d'Hebron /ID# 137098

    Barcelona, 08035

  • Hospital Sant Joan de Deu /ID# 137096

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario La Paz /ID# 137094

    Madrid, 28046

  • Hospital Universitario y Politecnico La Fe /ID# 137097

    Valencia, 46026

Other trials in Spain

Germany3 sites

  • Charite Universitaetsmedizin Berlin /ID# 141620

    Berlin, 10117

  • Universitaetsklinikum Freiburg /ID# 141618

    Freiburg im Breisgau, 79106

  • Helios Klinikum Wuppertal /ID# 142883

    Wuppertal, 42283

Other trials in Germany

Belgium2 sites

  • Cliniques Universitaires Saint-Luc /ID# 136910

    Brussels, Brussels Capital, 1200

  • UZ Leuven /ID# 136911

    Leuven, 3000

Other trials in Belgium

Puerto Rico1 site

  • San Jorge Children Hospital /ID# 136832

    San Juan, 00912-3310

Other trials in Puerto Rico

About this study

Official 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)

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.

Read the detailed 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.

Being tested
Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin, Ombitasvir mini tablet, Paritaprevir mini tablet
Keywords
Hepatitis C Virus, Hepatitis C Genotype 1, Hepatitis C Genotype 4, Pediatric
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ombitasvir/paritaprevir/ritonavirDrug

    Also called Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450, Ombitsvir/paritaprevir/ritonavir also known as Viekirax

    Film-coated tablet for oral use

  • DasabuvirDrug

    Also called Exviera, ABT-333

    Film-coated tablet for oral use

  • RibavirinDrug

    Film-coated tablet for oral use

  • Ombitasvir mini tabletDrug

    Also called ABT-267

    Film-coated tablet for oral use

  • Paritaprevir mini tabletDrug

    Also called ABT-450

    Film-coated tablet for oral use

  • Ritonavir mini tabletDrug

    Film-coated tablet for oral use

  • Dasabuvir mini tabletDrug

    Also called Exviera, ABT-333

    Film-coated tablet for oral use

  • Ribavirin solutionDrug

    Oral solution

Study groups in NCT02486406
Study groupRoleWhat they receive
Adult tablet, 12-17 yr, Part 1ExperimentalParticipants 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.
Receives: Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Dasabuvir; Drug: Ribavirin
Adult tablet, 12-17 yr, Part 2ExperimentalParticipants 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.
Receives: Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Dasabuvir; Drug: Ribavirin
Mini tablet, 9-11 yr, Part 1ExperimentalParticipants 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.
Receives: Drug: Ombitasvir mini tablet; Drug: Paritaprevir mini tablet; Drug: Ritonavir mini tablet; Drug: Dasabuvir mini tablet; Drug: Ribavirin solution
Mini tablet, 3-8 yr, Part 1ExperimentalParticipants 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.
Receives: Drug: Ombitasvir mini tablet; Drug: Paritaprevir mini tablet; Drug: Ritonavir mini tablet; Drug: Dasabuvir mini tablet; Drug: Ribavirin solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 2

  2. 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.

    Measured: At Week 2

  3. 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.

    Measured: At Weeks 2 and 8

  4. 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.

    Measured: At Week 2

  5. 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.

    Measured: At Week 2

  6. 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.

    Measured: At Weeks 2 and 8

  7. 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.

    Measured: At Week 2

  8. 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.

    Measured: At Week 2

  9. 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.

    Measured: At Weeks 2 and 8

  10. 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.

    Measured: At Week 2

  11. 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.

    Measured: At Week 2

  12. 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.

    Measured: At Weeks 2 and 8

  13. 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.

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

Secondary outcomes (3)

  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

    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.

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

  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

    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.

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

  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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study start28 Oct 2015
  3. Primary completion19 Nov 2020
  4. Study completion19 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486406
Sponsor's protocol ID
M14-748
Other IDs
2015-000111-41, 2015
Acronym
ZIRCON
Status last verified
Sep 2021
First submitted
17 Jun 2015
Last updated
5 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • 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.

    PubMed 32451952

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ombitasvir/paritaprevir/ritonavir, Dasabuvir and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Spain, Germany, Belgium, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV) (time frame: At Week 2). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02486406, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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