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NCT01967888 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT01967888: Completed Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT01967888 is a Phase 2 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967888, a Phase 2 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
The study is a phase 2/3, multicenter, double-blind, parallel assignment study. It involves 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT). The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by the proportion of insulin-independent patients following IAT. The safety of reparixin in the specific clinical setting will be also evaluated.
Primary Outcome
Insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycemic control, as defined by: * a glycated hemoglobin (HbA1c) level \<6.5%; * fingerstick fasting blood glucose not exceeding 126 mg/dL more than three times in the past week (based on a minimum of one daily measurement; * a 2 hour post-prandial blood glucose not exceeding 180 mg/dL more than four times in the past week (based on a minimum of one daily measurement
Interventions
- DRUG Placebo
- DRUG Reparixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT01967888 record still lists
NCT01967888 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01967888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967888 about?
NCT01967888 is a clinical study titled "Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation". The study is a phase 2/3, multicenter, double-blind, parallel assignment study. It involves 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT). The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by t...
What is the current status of trial NCT01967888?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2014-02. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01967888?
The interventions under investigation include: Placebo (DRUG), Reparixin (DRUG).
Who is sponsoring clinical trial NCT01967888?
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 NCT01967888's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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