Safety and efficacy of hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients. Part B: Clinical Study Protocol SC13: Safety of a 5 mg dose of hLF1-11 given for 10 consecutive days to autologous haematopoietic stem cell transplant recipients
Phase 2
- Conditions
- infecti10035227
- Registration Number
- NL-OMON31209
- Lead Sponsor
- AM-Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
· has been admitted for an autologous HSCT after myeloablative therapy with
high-dose melphalan;
· is being managed with a 3 or 4-lumen central venous catheter;
· is at least 18 years old;
· has a BMI < 30 kg/M2;
· has no medical reason for not participating;
· has adequate renal function (creatinine < 1.5 x ULN) ;
· has adequate liver function (ASAT, ALAT < 2.5 x ULN, bilirubin < 1.5 x ULN);
· if a woman, is functionally post-menopausal;
· has not participated in a study of a new chemical molecular entity in the
previous 3 months;
· is able and willing to participate;
· has provided written informed consent.
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability as measured by adverse events, laboratory<br /><br>abnormalities, alterations in vital signs and the elaboration of specific<br /><br>anti-hLF1-11 antibodies.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>