extention up to 3 years of the follow-up of patients treated with reparixin under protocol REP0110.
- Conditions
- Therapeutic area: Diseases [C] - Hormonal diseases [C19]patients who have received pancreatic islet transplantation
- Registration Number
- EUCTR2013-002244-86-IT
- Lead Sponsor
- Dompé s.p.a.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3
1. Patients enrolled and treated with reparixin in the REP0110 study.
2. Patients with a functioning graft at last follow-up visit (stimulated serum C-peptide levels > 0.3 ng/mL derived from the MMTT).
3. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
4. Patients who have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
not applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method