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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00358150
Eligibility Criteria:
Inclusion Criteria:
* The participant had a diagnosis of Gaucher Type I disease and a documented deficiency of glucocerebrosidase activity by enzyme assay and was willing and able to provide written informed consent prior to initiating any study-related procedures;
* The participant was 18 to 65 years old and weighed between 50 and 120 kilogram (kg) at enrollment;
* The participant had the following symptoms of Gaucher disease identified within 28 days of enrollment (at screening);
* Anemia - indicated by hemoglobin measurements taken during the screening phase (8 to 10 gram per deciliter (g/dL) if female, 8 to 11 g/dL if male);
* Thrombocytopenia - indicated by platelet count measurements taken during the screening phase (60000 to 100000 per cubic millimeter);
* Splenomegaly, as indicated by magnetic resonance imaging (MRI) or spiral computed tomography (CT) (\>= 10 multiples of normal);
* Female participants of child-bearing potential must had a documented negative serum pregnancy test prior to dosing. Female participants agreed to use a reliable method of birth control throughout duration of trial.
Exclusion Criteria:
* Participant had a partial or total splenectomy or infarcted areas of the spleen;
* Participant had documented prior bleeding varices or liver infarction;
* Participant received miglustat within 12 months prior to study enrollment;
* The participant had received an investigational product within 30 days prior to study enrollment;
* Participant had neurologic or pulmonary involvement;
* Participant had new pathological bone involvement or bone crisis in the 12 months prior to enrollment;
* Participant was transfusion-dependent;
* Participant had a documented etiology of anemia due to causes other than Gaucher disease;
* The participant had cardiac functional and/or anatomical abnormalities, a history of cancer or tested positive for human immunodeficiency virus (HIV) antibody or Hepatitis;
* Participant had a clinically significant disease, other than Gaucher disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, other medical conditions, or serious intercurrent illnesses that, in the opinion of the Investigator, might preclude participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00358150
Study Brief:
Protocol Section:
NCT00358150