Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Public ClinicalTrials.gov record NCT02175758. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.
Study identification
- NCT ID
- NCT02175758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 106 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2014 (Actual)
- Primary completion
- Jun 21, 2018 (Actual)
- Completion
- Sep 13, 2018 (Actual)
- Last update posted
- Apr 30, 2019
2014 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Angeles | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02175758, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2019 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02175758 live on ClinicalTrials.gov.