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NCT03152058 · ClinicalTrials.gov registry record · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
A Phase 2 study of Pregnancy Complications and High Risk Pregnancy, sponsored by David Ware Branch.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT03152058 is a Phase 2 study of Pregnancy Complications and High Risk Pregnancy that is actively recruiting participants, run by David Ware Branch. The registered enrollment target is 55 participants, below the 3,789-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03152058, a Phase 2 study of Pregnancy Complications and High Risk Pregnancy, is actively recruiting participants, sponsored by David Ware Branch.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study Summary
This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
Conditions Studied
Interventions
- DRUG Certolizumab Pegol
Study Locations (3)
New York
- Hospital for Special Surgery - New York
Utah
- University of Utah - Salt Lake City
Ontario
- TRIO Advancing Reproductive Care - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03152058
The ClinicalTrials.gov registry entry for NCT03152058 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,789-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (99% lower). The listed sponsor is David Ware Branch, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 1 intervention - of which Certolizumab Pegol is the first listed.
NCT03152058 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New York, Utah, Ontario.
Frequently Asked Questions
What is clinical trial NCT03152058 about?
NCT03152058 is a clinical study titled "IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy". This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this reg...
What is the current status of trial NCT03152058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2017-05-17. Estimated completion is 2026-12.
What conditions does trial NCT03152058 study?
This clinical trial studies the following conditions: Pregnancy Complications, High Risk Pregnancy, Antiphospholipid Syndrome in Pregnancy, Lupus Anticoagulant Disorder.
What interventions are being tested in trial NCT03152058?
The interventions under investigation include: Certolizumab Pegol (DRUG).
Who is sponsoring clinical trial NCT03152058?
This trial is sponsored by David Ware Branch, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03152058 being conducted?
This trial has 3 study locations across New York, Utah, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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