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

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ombitasvir/paritaprevir/ritonavir
Dasabuvir
Ribavirin
Ombitasvir mini tablet
Paritaprevir mini tablet
Ritonavir mini tablet
Dasabuvir mini tablet
Ribavirin solution
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Hepatitis C Virus, Hepatitis C Genotype 1, Hepatitis C Genotype 4, Pediatric

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Benioff Childrens Hosp /ID# 136774
  • Children's Hospital Colorado /ID# 137017
  • University of Florida - Archer /ID# 136830
  • Advent Health /ID# 167663
  • Indiana University /ID# 137015
  • Boston Childrens Hospital /ID# 137174
  • Boston Medical Center /ID# 136831
  • Columbia Univ Medical Center /ID# 136431
  • Children's Hospital of Philadelphia /ID# 137018
  • Baylor College of Medicine /ID# 136590
  • Seattle Children's Hospital /ID# 137019
  • Cliniques Universitaires Saint-Luc /ID# 136910
  • UZ Leuven /ID# 136911
  • Charite Universitaetsmedizin Berlin /ID# 141620
  • Universitaetsklinikum Freiburg /ID# 141618
  • Helios Klinikum Wuppertal /ID# 142883
  • San Jorge Children Hospital /ID# 136832
  • Hospital Sant Joan de Deu /ID# 137096
  • Hospital Universitario Vall d'Hebron /ID# 137098
  • Hospital Universitario La Paz /ID# 137094
  • Hospital Universitario y Politecnico La Fe /ID# 137097

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Adult tablet, 12-17 yr, Part 1

Adult tablet, 12-17 yr, Part 2

Mini tablet, 9-11 yr, Part 1

Mini tablet, 3-8 yr, Part 1

Arm Description

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 17, 2015
Last Updated
September 7, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02486406
Brief Title
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Acronym
ZIRCON
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
November 19, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection
Keywords
Hepatitis C Virus, Hepatitis C Genotype 1, Hepatitis C Genotype 4, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult tablet, 12-17 yr, Part 1
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Adult tablet, 12-17 yr, Part 2
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Mini tablet, 9-11 yr, Part 1
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Mini tablet, 3-8 yr, Part 1
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Ombitasvir/paritaprevir/ritonavir
Other Intervention Name(s)
Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450, Ombitsvir/paritaprevir/ritonavir also known as Viekirax
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Dasabuvir
Other Intervention Name(s)
Exviera, ABT-333
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Ombitasvir mini tablet
Other Intervention Name(s)
ABT-267
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Paritaprevir mini tablet
Other Intervention Name(s)
ABT-450
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Ritonavir mini tablet
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Dasabuvir mini tablet
Other Intervention Name(s)
Exviera, ABT-333
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Ribavirin solution
Intervention Description
Oral solution
Primary Outcome Measure Information:
Title
Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)
Description
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Time Frame
At Weeks 2 and 8
Title
Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)
Description
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Time Frame
At Weeks 2 and 8
Title
Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)
Description
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Time Frame
At Weeks 2 and 8
Title
Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)
Description
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.
Time Frame
At Week 2
Title
Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)
Description
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Time Frame
At Weeks 2 and 8
Title
Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)
Description
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.
Time Frame
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Title
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
Description
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.
Time Frame
24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
Title
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
Description
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.
Time Frame
12 or 24 weeks after starting study drug, depending on treatment duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Benioff Childrens Hosp /ID# 136774
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado /ID# 137017
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida - Archer /ID# 136830
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Advent Health /ID# 167663
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Indiana University /ID# 137015
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Boston Childrens Hospital /ID# 137174
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center /ID# 136831
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 136431
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Children's Hospital of Philadelphia /ID# 137018
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine /ID# 136590
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Seattle Children's Hospital /ID# 137019
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc /ID# 136910
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven /ID# 136911
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Charite Universitaetsmedizin Berlin /ID# 141620
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Freiburg /ID# 141618
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Helios Klinikum Wuppertal /ID# 142883
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
San Jorge Children Hospital /ID# 136832
City
San Juan
ZIP/Postal Code
00912-3310
Country
Puerto Rico
Facility Name
Hospital Sant Joan de Deu /ID# 137096
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 137098
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 137094
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 137097
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
32451952
Citation
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.
Results Reference
derived

Learn more about this trial

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

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