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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00954460
Eligibility Criteria:
Inclusion Criteria:
1. The patient has a documented diagnosis of type 1 Gaucher disease
2. The patient is \> 2 years of age
3. The patient has NOT previously experienced an anaphylactic or anaphylactoid reaction to another ERT including imiglucerase
4. Women of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study; and must have a negative result to a pregnancy test as required throughout their participation in the study. Male patients must use a medically acceptable method of birth control throughout their participation in the study and must report their partner's pregnancy.
5. The patient is sufficiently cooperative to participate in this treatment plan as judged by the Investigator
6. If the patient is naïve or new to treatment, the patient has one or more of the following (in absence of the following criteria, please call the sponsor for treatment justification):
* Gaucher disease-related anemia
* Moderate splenomegaly (2 to 3 cm below the left costal margin), by palpation
* Gaucher disease-related thrombocytopenia
* Gaucher disease-related palpable enlarged liver
Exclusion Criteria: None
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT00954460
Study Brief:
Protocol Section:
NCT00954460