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EPC quantification after G-CSF stimulation in healthy volunteers

EPC quantification after G-CSF stimulation in healthy volunteers - G-CSF study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31566
Enrollment
30
Registered
2007-08-30
Start date
2007-12-12
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

cancer malignancy

Interventions

Healthy volunteers who are willing to participate and who signed informed consent will be injected with a one time subcutaneous injection of filgrastim of 0.03 µg or saline 0.9% (1ml). Patients will

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.The volunteer must be >= 18 years of age 2.The volunteer must be healthy meaning having no relevant medical history and havind no clinical signs of intercurrent infection at physical exam at start of the study 3.The volunteer mustn*t have known hypersensitivity to the to be administrated drugs (filgrastim®) 4.The patient must have given written informed consent 5. women wild child bearing potential must have a negative serum pregnancy test 48 hrs before start

Exclusion criteria

Exclusion criteria: Any other condition by which the patient doesn*t meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Primary objective is: To determine whether a single subcutaneous injection of G-CSF induces an immediate (within six hours) release of bone marrow progenitor cells in healthy volunteers.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)