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NCT03524612 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
A Phase 2 study of Immune Thrombocytopenic Purpura (ITP), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT03524612: Completed Phase 2 study of Immune Thrombocytopenic Purpura (ITP), sponsored by Novartis Pharmaceuticals.
NCT03524612 is a Phase 2 study of Immune Thrombocytopenic Purpura (ITP) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03524612, a Phase 2 study of Immune Thrombocytopenic Purpura (ITP), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.
Primary Outcome
Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy until month 12.
Conditions Studied
Interventions
- DRUG eltrombopag
Study Locations (20)
Other
- Novartis Investigative Site - Linz
- Novartis Investigative Site - Caen
- Novartis Investigative Site - Pessac
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Pátrai
- Novartis Investigative Site - Mexico City
- Novartis Investigative Site - Muscat
- Novartis Investigative Site - Moscow
- Novartis Investigative Site - Saint Petersburg
New York
- Hematology Oncology Association of Rockland - Nyack
Ohio
- Case Western Reserve - Cleveland
Estado de Bahia
- Novartis Investigative Site - Salvador
Rio de Janeiro
- Novartis Investigative Site - Rio de Janeiro
São Paulo
- Novartis Investigative Site - São Paulo
Región de la Araucanía
- Novartis Investigative Site - Temuco
Región de Valparaíso
- Novartis Investigative Site - Viña del Mar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-11-02 |
| Est. Completion | 2022-10-03 |
| Phase | Phase 2 |
What the finished NCT03524612 record still lists
NCT03524612 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Immune Thrombocytopenic Purpura (ITP) appearing as the primary indexed condition, and to 1 intervention - of which eltrombopag is the first listed.
NCT03524612 names 20 study sites across 12 states, led by Other, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT03524612 about?
NCT03524612 is a clinical study titled "A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP". The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.
What is the current status of trial NCT03524612?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2018-11-02. Estimated completion is 2022-10-03.
What conditions does trial NCT03524612 study?
This clinical trial studies the following conditions: Immune Thrombocytopenic Purpura (ITP).
What interventions are being tested in trial NCT03524612?
The interventions under investigation include: eltrombopag (DRUG).
Who is sponsoring clinical trial NCT03524612?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03524612 being conducted?
This trial has 20 study locations across New York, Ohio, Estado de Bahia, Rio de Janeiro, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03524612's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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