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NCT01978366 · ClinicalTrials.gov registry record · Phase 2
Open Label Extension Study of HT-100 in Patients With DMD
A Phase 2 study, sponsored by Processa Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01978366: Clinical Trial Phase 2 study, sponsored by Processa Pharmaceuticals.
NCT01978366 is a Phase 2 study that was terminated before completion, run by Processa Pharmaceuticals. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01978366, a Phase 2 study, was terminated before completion, sponsored by Processa Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This study is designed to provide 6-months continuous dosing with the study medication, called HT-100, on participants who successfully completed the predecessor study (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability, pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics (measuring how much drug is in the bloodstream) in participants with a broad spectrum of Duchenne muscular dystrophy (DMD).
Primary Outcome
* Target Safety profile by review of adverse events (AEs) * Physical examination findings * Clinical laboratory test results * Other diagnostic testing
Interventions
- DRUG HT-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04-30 |
| Phase | Phase 2 |
Why NCT01978366 stopped before completion
NCT01978366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which HT-100 is the first listed.
NCT01978366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01978366 about?
NCT01978366 is a clinical study titled "Open Label Extension Study of HT-100 in Patients With DMD". This study is designed to provide 6-months continuous dosing with the study medication, called HT-100, on participants who successfully completed the predecessor study (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability, pharmacodynamic activity (testing the drug'...
What is the current status of trial NCT01978366?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2013-10. Estimated completion is 2016-04-30.
What interventions are being tested in trial NCT01978366?
The interventions under investigation include: HT-100 (DRUG).
Who is sponsoring clinical trial NCT01978366?
This trial is sponsored by Processa Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01978366's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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