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NCT07127978 · ClinicalTrials.gov registry record
A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
A clinical trial of Duchene Muscular Dystrophy, sponsored by ITF Therapeutics.
- Recruiting
- Registry status
- 300
- Enrollment target
- 2
- Study locations
NCT07127978: Recruiting study of Duchene Muscular Dystrophy, sponsored by ITF Therapeutics.
NCT07127978 is a study of Duchene Muscular Dystrophy that is actively recruiting participants, run by ITF Therapeutics. The registered enrollment target is 300 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07127978, a study of Duchene Muscular Dystrophy, is actively recruiting participants, sponsored by ITF Therapeutics.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years of follow-up.
Primary Outcome
Incidence rate of thrombocytopenia (per 100 patient years of observation time) post index date
Conditions Studied
Study Locations (2)
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- University of Massachusetts Chan Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2030-07-30 |
What NCT07127978 shows while recruiting
NCT07127978 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Duchene Muscular Dystrophy appearing as the primary indexed condition, and to 0 interventions.
NCT07127978 reports a single indexed study location in Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07127978 about?
NCT07127978 is a clinical study titled "A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy". This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 year...
What is the current status of trial NCT07127978?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2025-10-23. Estimated completion is 2030-07-30.
What conditions does trial NCT07127978 study?
This clinical trial studies the following conditions: Duchene Muscular Dystrophy.
Who is sponsoring clinical trial NCT07127978?
This trial is sponsored by ITF Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07127978 being conducted?
This trial has 2 study locations across Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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