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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00001410 |
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Date of registration:
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03/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PEG-Glucocerebrosidase for the Treatment of Gaucher Disease
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Scientific title:
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A Phase I and II Study of PEG-Glucocerebrosidase in Patients With Type 1 or Type 3 Gaucher Disease |
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Date of first enrolment:
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October 1993 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001410 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Patients must be at least 3 years of age.
Must have a biochemically confirmed (enzyme) and/or genetically confirmed diagnosis of
type 1 or type 3 Gaucher disease.
Clinical or laboratory signs suggesting need for therapy which will include at least 2 of
the following: hemoglobin less than 11 gm/dl; platelets less than 90,000/mm(3);
hepatomegaly and/or splenomegaly.
Patient/Guardian must provide written informed consent.
No pregnant or breast feeding women.
No women/men of reproductive potential unless they agree to use an effective contraceptive
method.
No patients treated with alglucerase or imiglucerase during the 6 months prior to study
entry.
No patients with the diagnosis of type 2 Gaucher disease.
No patients who have a life-threatening disease or are gravely ill.
No patients who have rapidly progressing fatal illness or concomitant malignancy.
No patients who have a chronic infectious disease including HIV or hepatitis B.
No patients chronically on other medications which may interfere with the drug's
metabolism or activity.
No patients who received blood transfusion within a month prior to study entry.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gaucher's Disease
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Intervention(s)
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Drug: Lysodase
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Secondary ID(s)
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940014
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94-M-0014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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