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NCT07001254 · ClinicalTrials.gov registry record · Phase 2
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia
A Phase 2 study, sponsored by Anjali Sharathkumar.
- Not yet
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT07001254: Clinical Trial Phase 2 study, sponsored by Anjali Sharathkumar.
NCT07001254 is a Phase 2 study that has not yet begun recruiting, run by Anjali Sharathkumar. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07001254, a Phase 2 study, has not yet begun recruiting, sponsored by Anjali Sharathkumar.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This Phase II open-label interventional clinical trial aims to evaluate the efficacy of romiplostim, in patients with severe aplastic anemia (SAA), both treatment naïve and relapsed/refractory, in inducing trilineage hematopoiesis in children and young adults.
Primary Outcome
Proportion of participants with hematopoietic complete response at 24 weeks defined as hemoglobin ≥10 g/dL, ANC ≥1 x 10\^9/L, and platelet count ≥100 x 10\^9/L without having received transfusion of packed red blood cells within the last 6 weeks or platelets or G-CSF/GM-CSF within the last 2 weeks.
Interventions
- DRUG Romiplostim
- DRUG Immunosuppressive therapy (IST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What is known before NCT07001254 opens enrollment
NCT07001254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Romiplostim is the first listed.
NCT07001254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07001254 about?
NCT07001254 is a clinical study titled "UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia". This Phase II open-label interventional clinical trial aims to evaluate the efficacy of romiplostim, in patients with severe aplastic anemia (SAA), both treatment naïve and relapsed/refractory, in inducing trilineage hematopoiesis in children and young adults.
What is the current status of trial NCT07001254?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2026-08-01. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07001254?
The interventions under investigation include: Romiplostim (DRUG), Immunosuppressive therapy (IST) (DRUG).
Who is sponsoring clinical trial NCT07001254?
This trial is sponsored by Anjali Sharathkumar, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07001254's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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