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NCT03997760 · ClinicalTrials.gov registry record · Phase 1
A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03997760: Completed Phase 1 study, sponsored by Shire.
NCT03997760 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997760, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
TAK-755 (previously known as SHP655) is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of TAK-755 in SCD participants. Study participants will receive TAK-755 or placebo on Day 1. Their SCD will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be asked to follow-up on 13 days following SHP655 or placebo administration for safety assessment. Maximum duration of participation is expected to be about 2 months.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. TEAEs were defined as AEs that started or worsened in severity on or after the infusion of IP. A serious TEAEs was any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not an
Interventions
- OTHER Placebo
- DRUG TAK-755
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2022-10-26 |
| Phase | Phase 1 |
What the finished NCT03997760 record still lists
NCT03997760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03997760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03997760 about?
NCT03997760 is a clinical study titled "A Study of SHP655 (rADAMTS13) in Sickle Cell Disease". TAK-755 (previously known as SHP655) is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of TAK-755 in SCD participants. Study participants will receive TAK-755 or placebo on Day 1. Their SCD will be treated by their doctor acco...
What is the current status of trial NCT03997760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-10-21. Estimated completion is 2022-10-26.
What interventions are being tested in trial NCT03997760?
The interventions under investigation include: Placebo (OTHER), TAK-755 (DRUG).
Who is sponsoring clinical trial NCT03997760?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03997760's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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