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



Status:Active, not recruiting
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:3/21/2019
Start Date:October 28, 2015
End Date:November 26, 2020

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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)

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.


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.
We found this trial at
12
sites
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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13123 East 16th Avenue
Aurora, Colorado 80045
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Aurora, CO
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300 Longwood Avenue
Boston, Massachusetts 02115
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Boston, MA
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Boston, Massachusetts 02118
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Boston, MA
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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630 West 168th Street
New York, New York 10032
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New York, NY
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Orlando, Florida 32803
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Orlando, FL
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505 Parnassus Avenue
San Francisco, California 94143
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San Francisco, CA
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4800 Sand Point Way Northeast
Seattle, Washington 98105
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Seattle, WA
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Woluwe-Saint-Lambert, Bruxelles-Capitale
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Woluwe-Saint-Lambert,
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