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NCT01959321 · ClinicalTrials.gov registry record
An Observational Study of Hepatitis C Virus in Pregnancy
A clinical trial of Hepatitis C, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- 772
- Enrollment target
- 17
- Study locations
NCT01959321: Completed study of Hepatitis C, sponsored by The George Washington University Biostatistics Center.
NCT01959321 is a study of Hepatitis C that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 772 participants, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (59% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959321, a study of Hepatitis C, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- 772 participants
- Enrollment target
- 17
- Study locations
Study Summary
This multi-center observational study examines risk factors for HCV transmission from mother to baby.
Primary Outcome
The primary outcome is HCV infection of the offspring, where infection is defined by satisfying any one of the following criteria: * HCV RNA positive (i.e. presence of viral load) by polymerase chain reaction (PCR) test at 2-6 months (2 month visit) * HCV RNA positive and HCV antibody positive at the 18-24 months (18 month visit) * HCV RNA positive at 18-24 months with a negative HCV antibody at 18-24 months and negative RNA at 2-6 months. However, the positive result must be confirmed by a rep
Conditions Studied
Study Locations (17)
Texas
- University of Texas Southwestern Medical Center - Dallas
- University of Texas - Galveston - Galveston
- University of Texas - Houston - Houston
North Carolina
- University of North Carolina - Chapel Hill - Chapel Hill
- Duke University - Durham
Ohio
- Case Western Reserve University - Cleveland
- Ohio State University - Columbus
Pennsylvania
- University of Pennsylvania - Philadelphia
- Magee Women's Hospital of UPMC - Pittsburgh
Alabama
- University of Alabama - Birmingham - Birmingham
California
- Stanford University - Stanford
Colorado
- University of Colorado - Denver
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 772 participants |
| Start Date | 2012-10 |
| Est. Completion | 2021-06-30 |
What the finished NCT01959321 record still lists
NCT01959321 is an observational study that tracks outcomes without assigning an intervention. The registered 772 participants enrollment target is mid-sized for trials with a published cap, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 0 interventions.
NCT01959321 lists 17 locations in 12 states (Texas, North Carolina, Ohio).
Frequently Asked Questions
What is clinical trial NCT01959321 about?
NCT01959321 is a clinical study titled "An Observational Study of Hepatitis C Virus in Pregnancy". This multi-center observational study examines risk factors for HCV transmission from mother to baby.
What is the current status of trial NCT01959321?
This trial is currently completed. The enrollment target is 772 participants. The study started on 2012-10. Estimated completion is 2021-06-30.
What conditions does trial NCT01959321 study?
This clinical trial studies the following conditions: Hepatitis C.
Who is sponsoring clinical trial NCT01959321?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01959321 being conducted?
This trial has 17 study locations across Alabama, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01959321's enrollment target sits among peer trials
772 10th of 106 higher than 97 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
DBS TaT in Peer-assisted Telemedicine for Hepatitis C
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The HOPE Study: Characterizing Patients With Hepatitis B and C
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Project I Test: Implementing HIV Testing in Opioid Treatment Programs
RECRUITING · NA
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Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
RECRUITING · NA
-
The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
RECRUITING
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