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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 is a Phase 2 study that was terminated before completion, run by Processa Pharmaceuticals. The registered enrollment target is 17 participants.
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).
Interventions
- DRUG HT-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01978366
The ClinicalTrials.gov registry entry for NCT01978366 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Processa Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HT-100 is the first listed.
NCT01978366 reports 0 study locations.
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.
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