Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02530996 · ClinicalTrials.gov registry record · Phase 1
Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02530996: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT02530996 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02530996, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by activation of immune cells, which results in vascular dysfunction (vasculopathy) and subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military. On a national level there are 5,766 SSc patients (ICD-9 710.1) presently cared for in the Veterans Health Administration (VHA). While there is no cure for SSc, studies of therapeutics that can help slow disease progression are valuable to our Veterans. This proposal addresses the solicitation for projects with attention to SSc requested by President Obama after reviewing potential contamination of water at Camp Lejeune. This proposal is a patient-centered outreach for our Veterans with SSc to inform and prevent catastrophic endstage vascular abnormalities, including digital ulcers, pulmonary arterial hypertension (PAH) and scleroderma renal crisis in SSc. The study proposes a novel application of a therapeutic for this disease. A better understanding of the initiating insult and natural progression of SSc vasculopathy is needed in order to develop therapeutics with a goal of curing/treating the underlying disease. This project has the potential to impact not only Veterans with SSc, but also those with vascular abnormalities including digital ulcers, PAH, and renal crisis. This proposal represents a potential major therapeutic advance for our Veterans with SSc.
Interventions
- DRUG Placebo
- DRUG BH4
- DIAGNOSTIC_TEST Vasculopathy assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02530996
The ClinicalTrials.gov registry entry for NCT02530996 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02530996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02530996 about?
NCT02530996 is a clinical study titled "Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment". Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by activation of immune cells, which results in vascular dysfunction (vasculopathy) and subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military. On a national level there are 5,76...
What is the current status of trial NCT02530996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-01-01. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT02530996?
The interventions under investigation include: Placebo (DRUG), BH4 (DRUG), Vasculopathy assessment (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02530996?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.