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A phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients.


- candidate number8918
- NTR NumberNTR2685
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2011
- Secondary IDsP10.85 / NL31947.058.10 ; METC LUMC / ABR
- Public TitleA phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients.
- Scientific TitleA phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients.
- ACRONYM
- hypothesisThe objective of this proof-of-concept study is to test in no-option CLI patients whether ARA 290 (a) reduces limb pain, (b) reduces signs of local and systemic inflammation, and (c) promotes wound healing.
- Healt Condition(s) or Problem(s) studiedCritical limb ischemia
- Inclusion criteria1. Critical limb ischemia;
2. No option for conventional revascularization;
3. Written informed consent;
4. Expected life expectancy > 1 year.
- Exclusion criteria1. Poorly regulated diabetic disease (HbA1c >10%);
2. Clinically relevant abnormal history of physical and mental health other than conditions related to CLI, as determined by medical history taking (as judged by the investigator);
3. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to CLI (as judged by the investigator);
4. Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
5. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;
6. Use of erythropoietin, systemic corticosteroids (e.g. prednisone etc.) and other immune modulatory drugs;
7. Inability to follow the protocol and to comply with the follow up requirements;
8. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-jan-2011
- planned closingdate31-dec-2011
- Target number of participants12
- InterventionsARA 290 is an 11-amino acid, linear peptide that is being developed as a tissue protective peptide. ARA 290 is manufactured by standard F-moc solid phase peptide synthesis, purified by HPLC and ion-exchange chromatography, and stored as a lyophilized powder. ARA-290 will be administered 3 times a week for 4 weeks.
- Primary outcome1. Safety and tolerability parameters;
2. General safety measurements;
3. 12-lead ECG (only base line and visits on day 5 and 26);
4. Hematology;
5. Blood Biochemistry;
6. Adverse Event monitoring;
7. Pain Scores (VAS + Brief Pain Inventory);
8. Allodynia and Hyperalgesia Testing;
9. Autonomic nervous system measurement (only baseline and day 5);
10. Analgesics use (diary);
11. Wound healing (calibrated photos);
12. Circulating inflammatory markers;
13. Insulin sensitivity (fasting HOMA);
14. Quality of life (RAND-36) (only base line and day 26).
- Secondary outcomeN/A
- TimepointsDay 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. PhD. Jan H.N. Lindeman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Jan H.N. Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-jan-2011 - 16-nov-2017


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