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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02486406
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this three part study is to evaluate the pharmacokinetics (Part 1), safety/efficacy (Part 2), and long-term follow-up (Part 3) 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: paritaprevir Drug: ombitasvir Drug: dasabuvir Drug: ribavirin Drug: ritonavir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 28, 2015
Estimated Primary Completion Date : November 26, 2020
Estimated Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Genotype 4, with or without compensated cirrhosis
12 weeks of treatment
Drug: paritaprevir
Drug: ombitasvir
Drug: ribavirin
Drug: ritonavir
Experimental: Genotype 1a, without cirrhosis
12 weeks of treatment
Drug: paritaprevir
Drug: ombitasvir
Drug: dasabuvir
Drug: ribavirin
Drug: ritonavir
Experimental: Genotype 1a, with compensated cirrhosis
24 weeks of treatment
Drug: paritaprevir
Drug: ombitasvir
Drug: dasabuvir
Drug: ribavirin
Drug: ritonavir
Experimental: Genotype 1b, with or without compensated cirrhosis
12 weeks of treatment
Drug: paritaprevir
Drug: ombitasvir
Drug: dasabuvir
Drug: ritonavir



Primary Outcome Measures :
  1. Part1: Maximum plasma concentration (Cmax) of OBV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  2. Part 1: Maximum plasma concentration (Cmax) of PTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  3. Part 1: Lowest plasma concentration (Ctrough) of OBV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  4. Part 1: concentration of drug in blood plasma against time [Area under the curve (AUC)] of OBV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  5. Part 1: concentration of drug in blood plasma against time [Area under the curve (AUC)] of RTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  6. Part 1: concentration of drug in blood plasma against time [Area under the curve (AUC)] of PTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  7. Part 1: Maximum plasma concentration (Cmax) of DSV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  8. Part 1: Lowest plasma concentration (Ctrough) of DSV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  9. Part 1: concentration of drug in blood plasma against time [Area under the curve (AUC)] of DSV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  10. Part 3: Percentage of participants who relapse out of participants who achieved sustained virologic response (SVR) in Part 1 or Part 2 of the study. [ Time Frame: Any time up to the last follow-up in this study, approximately 4 years. ]
    Relapse is defined as confirmed HCV RNA ≥ LLOQ for a subject with HCV RNA < LLOQ at Final Treatment Visit who completes treatment

  11. Part 1: Maximum plasma concentration (Cmax) of RTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  12. Part 1: Lowest plasma concentration (Ctrough) of PTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  13. Part 1: Lowest plasma concentration (Ctrough) of RTV [ Time Frame: Pharmacokinetic (PK) samples will be collected at the following timepoints: • Day 1: 4 hours postdose • Week 2: 2, 4, 8, 12 and 24 hours postdose • Week 4: a PK sample • Week 8: a trough PK sample • Week 12: a PK sample ]
  14. Parts 1 and 2: Percentage of participants with sustained virologic response 12 weeks after the last actual dose of study drug (SVR12). [ Time Frame: Either 24 weeks or 36 weeks after starting study drug depending on treatment duration (12 or 24 weeks of treatment respectively). ]
    HCV RNA < Lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug

  15. Part 3: Percentage of participants who have new HCV infection [ Time Frame: Any time up to the last follow-up in this study, approximately 3 years. ]
    The percentage of participants who have new HCV infection at any time up to the last follow-up in this study out of participants who achieved SVR in Part 1 or Part 2.


Secondary Outcome Measures :
  1. Parts 1 and 2: Percentage of subjects who achieve SVR12 summarized by formulation, age and weight group and across all subjects on the adult formulations. [ Time Frame: 24 weeks after starting study drug depending on treatment duration. ]
    HCV RNA < LLOQ 12 weeks after the last actual dose of study drug

  2. Parts 1 and 2: Percentage of participants who achieve SVR24 by formulation, age and weight group, across all the subjects, and across all subjects on the adult formulations. [ Time Frame: 36 weeks after starting study drug depending on treatment duration. ]
    HCV RNA < LLOQ 24 weeks after the last actual dose of study drug

  3. Part 3: Assess the impact of OBV, PTV, RTV with or without DSV and with or without RBV on height [ Time Frame: Any time up to the last follow-up in this study, approximately 4 years. ]
  4. Part 3: Assess the impact of OBV, PTV, RTV with or without DSV and with or without RBV on waist circumference [ Time Frame: Any time up to the last follow-up in this study, approximately 4 years. ]
  5. Part 3: Assess the impact of OBV, PTV, RTV with or without DSV and with or without RBV on tanner staging [ Time Frame: Any time up to the last follow-up in this study, approximately 4 years. ]
  6. Parts 1 and 2: Percentage of participants with Alanine aminotransferase (ALT) normalization during treatment [ Time Frame: During the treatment period (either 12 or 24 weeks) ]
    ALT less than or equal to upper limit of normal (ULN) at the final treatment visit for participants with ALT greater than ULN at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Positive anti-HCV Ab and HCV RNA greater than or equal to 1000 IU/mL at the time of screening.
  2. HCV genotype 1 for enrollment into Part 1 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. Women who are pregnant, breastfeeding or are 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-HIV 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 IFNs or RBV or receipt of any investigational product within 6 weeks prior to study drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486406


Locations
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United States, California
Univ California, San Francisco /ID# 136774
San Francisco, California, United States, 94143-2204
United States, Colorado
Children's Hospital Colorado /ID# 137017
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida /ID# 136830
Gainesville, Florida, United States, 32610
Florida Hospital /ID# 167663
Orlando, Florida, United States, 32803
United States, Indiana
Indiana University /ID# 137015
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Childrens Hospital /ID# 137174
Boston, Massachusetts, United States, 02115
Boston Medical Center /ID# 136831
Boston, Massachusetts, United States, 02118
United States, New York
Columbia Univ Medical Center /ID# 136431
New York, New York, United States, 10032-3725
United States, Pennsylvania
Children's Hosp Philadelphia /ID# 137018
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine /ID# 136590
Houston, Texas, United States, 77030-3411
United States, Washington
Seattle Children's Hospital /ID# 137019
Seattle, Washington, United States, 98105
Belgium
Cliniques Universitaires Saint Luc /ID# 136910
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Leuven /ID# 136911
Leuven, Belgium, 3000
Germany
Charité Universitätsmedizin Campus Mitte /ID# 141620
Berlin, Germany, 10117
Universitätsklinikum Freiburg /ID# 141618
Freiburg, Germany, 79106
Helios Klinikum Wuppertal /ID# 142883
Wuppertal, Germany, 42283
Puerto Rico
San Jorge Children Hospital /ID# 136832
San Juan, Puerto Rico, 00912-3310
Spain
Hospital Univ Vall d'Hebron /ID# 137098
Barcelona, Spain, 08035
Hospital Sant Joan de Deu /ID# 137096
Esplugues de Llobregat, Spain, 08950
Hospital Universitario La Paz /ID# 137094
Madrid, Spain, 28046
Hospital Universitario La Fe /ID# 137097
Valencia, Spain, 46026
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02486406     History of Changes
Other Study ID Numbers: M14-748
2015-000111-41 ( EudraCT Number )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Hepatitis C Virus
Hepatitis C Genotype 1
Hepatitis C Genotype 4
Pediatric

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors