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

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 - Safety of hLF1-11 in autologous HSCTrecipients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31209

Enrollment

Registered

2007-06-12

Start date

2007-04-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infecti

Interventions

5 mg hLF1-11 given once daily for 10 consecutive days

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as measured by adverse events, laboratory abnormalities, alterations in vital signs and the elaboration of specific anti-hLF1-11 antibodies.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)