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NCT04253236 · ClinicalTrials.gov registry record · Phase 2
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
A Phase 2 study, sponsored by Immunovant Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04253236: Clinical Trial Phase 2 study, sponsored by Immunovant Sciences.
NCT04253236 is a Phase 2 study that was terminated before completion, run by Immunovant Sciences. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04253236, a Phase 2 study, was terminated before completion, sponsored by Immunovant Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
Primary Outcome
Responders were defined as the participants with level of hemoglobin (Hb) \>=10 grams per deciliter (g/dL) with at least a \>=2 g/dL increase from Baseline without rescue therapy or blood transfusions in the previous two weeks.
Interventions
- DRUG RVT-1401 680 mg/weekly
- DRUG RVT-1401 340 mg/weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
Why NCT04253236 stopped before completion
NCT04253236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which RVT-1401 680 mg/weekly is the first listed.
NCT04253236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04253236 about?
NCT04253236 is a clinical study titled "To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).". This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
What is the current status of trial NCT04253236?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2020-08-11. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT04253236?
The interventions under investigation include: RVT-1401 680 mg/weekly (DRUG), RVT-1401 340 mg/weekly (DRUG).
Who is sponsoring clinical trial NCT04253236?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04253236's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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