None listed
Conditions
Interventions
THE PATIENT WILL RECEIVE A SUBCUTANEOUS SINGLE DAILY DOSE OF SEMULOPARIN FOR A MINIMUM OF 6 DAYS AND A MAXIMUM OF30 DAYS.
THE STUDY DESIGN IS ILLUSTRATED BY THE GRAPH IN SECTION 1.1 AND THE STUDY F
12 TO < 18 YEARS). FOR GROUP 2 (AGED ≥
6 TO < 12 YEARS), GROUP 3 (AGED ≥
2 TO < 6 YEARS) AND GROUP 4 (AGED ≥
3 MONTHS TO < 2 YEARS) ENROLMENT MUST FOLLOW REVIEW BY THE EXTEMAL DMC OF THE CLINICAL SAFETY AND AVAILABLE PK AND PD DATA FROM THE FIRST 3 OUT OF 7 CHILDREN FROM THE PREVIOUS OLDER AGE GROUP. ENROLME
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 101. AGE: BETWEEN ≥ 38 GESTATIONAL WEEKS AND < 18 YEARS, 1 02. CVL IMPLANTED FOR AN EXPECTED DURATION ≥ 6 DAYS FROM STUDY ENROLMENT, 103. HOSPITALIZED OR ABLE TO RECEIVE DAILY INJECTION FOR AT LEAST 6 DAYS AND PROVIDE PLASMA SAMPLES AT DAY 4, 5 AND 6 AT THE PRE-SPECIFIED TIME POINTS, 104. WRITTEN INFORMED CONSENT SIGNED BY LEGAL REPRESENTATIVE(S) IN ACCORDANCE WITH LOCAL REGULATION, AND POSSIBLY ASSENT FORM BY THE CHILD (COUNTRY/AGE SPECIFIC).
Exclusion criteria
Exclusion criteria: 1. EXCLUSION CRITERIA RELATED TO STUDY METHODOLOGY E 01. PATIENT FOR WHOM ANTICOAGULANT THERAPY IS CONTRAINDICATED. E 02. PLANNED TREATMENT WITH OTHER ANTITHROMBOTIC AGENTS WITHIN 2 WEEKS PRIOR TO ENROLMENT AND DURING THE COURSE OFTHE STUDY. NOTE: PROPHYLAXIS OFCVL BLOCKAGE BY CONTINUOUS HEPARIN INFUSION (1-3 UNITS/ML) OR INTERMITTENT HEPARINJLUSHES (50-100 UNITS/ML UP TO 4 TIMES PER DAY) IS ALLOWED. PK/PD SAMPLES CANNOT BE DRAWN THROUGH THE CVL IF HEPARIN OR HEPARINOIDS ARE (OR HAVE BEEN) USED FOR PROPHYLAXIS OF CVL BLOCKAGE. NOTE: TREATMENT WITH ANTI-PLATELET AGENTS SUCH AS LOW DOSE ASPIRIN, OR CLOPIDOGREL IS ALLOWED WHEN IN ACCORDANCE WITH STANDARD CLINICAL PRACTICE. E 03. ANY PREVIOUS EXPOSURE TO AVE5026 (EG. PREVIOUS ENROLMENT IN THE CURRENT STUDY). E 04. DOCUMENTED HISTORY OF HEPARIN-INDUCED THROMBOCYTOPENIA. E 05. SEVERE THROMBOCYTOPENIA (PLATELETS <50 X 10 9/L), E 06. ACTIVE BLEEDING. E 07. RECENT (LESS THAN 3 WEEKS PRIOR TO ENROLMENT) BRAIN, SPINAL OR OPHTHALMOLOGIC SURGERY.
Countries
Hungary
Contacts
Public ContactCarolina Valladares
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed