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NCT01817959 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation
A Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT01817959 is a Phase 3 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 51 participants.
The verdict
NCT01817959, a Phase 3 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The objective of this clinical trial was: \- to assess whether Reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in patients with Type 1 diabetes (T1D). The safety of Reparixin in the specific clinical setting was also evaluated. Background: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantation. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in T1D patients.
Interventions
- DRUG Placebo
- DRUG Reparixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01817959
The ClinicalTrials.gov registry entry for NCT01817959 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01817959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01817959 about?
NCT01817959 is a clinical study titled "Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation". The objective of this clinical trial was: \- to assess whether Reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in patients with Type 1 diabetes (T1D). The safety of Reparixin in the specific clinical setting was a...
What is the current status of trial NCT01817959?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2012-10. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01817959?
The interventions under investigation include: Placebo (DRUG), Reparixin (DRUG).
Who is sponsoring clinical trial NCT01817959?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
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