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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: Completed Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
NCT01817959 is a Phase 3 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MMTT was to be performed ideally after an overnight fast. The test was to be initiated before 10 a.m. The Boost Original complete nutritional drink (Nestlé Nutrition) was used for the MMTT. Subjects were given 6 mL/kg of Boost preparation up to a maximum of 360 mL, to be drunk within 5 min. Blood samples for the C-peptide assay (the primary assessment) were withdrawn in fasting condition (basal), just prior to the meal (time 0, within 15 min prior to the meal) and then at 15, 30, 60, 90, 120
Interventions
- DRUG Placebo
- DRUG Reparixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
What the finished NCT01817959 record still lists
NCT01817959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01817959 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01817959's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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