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NCT04188379 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
A Phase 3 study of Primary Immune Thrombocytopenia, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT04188379: Completed Phase 3 study of Primary Immune Thrombocytopenia, sponsored by argenx.
NCT04188379 is a Phase 3 study of Primary Immune Thrombocytopenia that has completed, run by argenx. The registered enrollment target is 131 participants, above the 107-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04188379, a Phase 3 study of Primary Immune Thrombocytopenia, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
Primary Outcome
Percentage of participants with chronic ITP with a sustained platelet count response was defined as achieving platelet counts of at least 50 × 10\^9/L for at least 4 of the 6 visits between Week 19 and 24 of the study.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL efgartigimod
Study Locations (20)
Other
- Investigator Site 0430004 - Linz
- Investigator Site 0430002 - Vienna
- Investigator Site 0430003 - Vienna
- Investigator Site 0320012 - Brasschaat
- Investigator Site 0320011 - Bruges
- Investigator Site 0320015 - Leuven
- Investigator Site 0320014 - Turnhout
- Investigator Site 0320020 - Verviers
- Investigator site 0320002 - Yvoir
- Investigator Site 3590001 - Pleven
- Investigator Site 3590002 - Sofia
Florida
- Investigator Site 0010034 - Jacksonville
- Investigator site 0010037 - Ocala
Ohio
- Investigator Site 0010049 - Cleveland
- Investigator Site 0010040 - Columbus
Arizona
- Investigator Site 0010038 - Tucson
District of Columbia
- Investigator Site 0010045 - Washington D.C.
Iowa
- Investigator Site 0010042 - Iowa City
North Carolina
- Investigator Site 0010046 - Greenville
Pennsylvania
- Investigator Site 0010041 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 3 |
What the finished NCT04188379 record still lists
NCT04188379 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Primary Immune Thrombocytopenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04188379 names 20 study sites across 8 states, led by Other, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04188379 about?
NCT04188379 is a clinical study titled "A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).". This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
What is the current status of trial NCT04188379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2019-12-16. Estimated completion is 2022-02-03.
What conditions does trial NCT04188379 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia.
What interventions are being tested in trial NCT04188379?
The interventions under investigation include: Placebo (OTHER), efgartigimod (BIOLOGICAL).
Who is sponsoring clinical trial NCT04188379?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04188379 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, Florida, Iowa, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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