Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01000051
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>/= 35 days post HCT with Platelet count \</= 20 x 10\^9/l sustained for 7 days or patients are platelet transfusion dependent, and
2. Neutrophil count \>/= 1.5 x 10\^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and
3. Age \>/= 18
Exclusion Criteria:
1. Recurrence or progression of primary malignancy after HCT
2. ALT \>/= 2.5 times the ULN
3. Serum bilirubin \>2mg/dl (unless due to Gilbert's syndrome)
4. Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.
5. ECOG Performance status \>2
6. Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization. A negative pregnancy test result will be required before any study drug is given.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01000051
Study Brief:
Protocol Section:
NCT01000051