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Re: MPS 1 updated april 26 but i dont see what changed ?found the updates now Current Primary Outcome Measures ICMJE (submitted: April 26, 2017) Treatment related Adverse Events in subjects who received SB-318 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 36 months after the SB-318 infusion ] Assessment of treatment related Adverse Events in subjects who received SB-318 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Original Primary Outcome Measures ICMJE (submitted: March 2, 2016) Treatment related Adverse Events in subjects who received SB-318 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 36 months after the SB-318 infusion ] Change History Complete list of historical versions of study NCT02702115 on ClinicalTrials.gov Archive Site Current Secondary Outcome Measures ICMJE (submitted: April 26, 2017) Effect of SB-318 on urine glycosaminoglycans (GAG) levels [ Time Frame: Up to 36 months after the SB-318 infusion ] Measurement of effect of SB-318 on urine glycosaminoglycans (GAG) levels AAV2/6 clearance in plasma, saliva, urine, stool, and semen [ Time Frame: Up to 36 months after the SB-318 infusion ] Measurement of AAV2/6 clearance in plasma, saliva, urine, stool, and semen Original Secondary Outcome Measures ICMJE (submitted: March 2, 2016) Effect of SB-318 on leukocyte IDUA activity [ Time Frame: Up to 36 months after the SB-318 infusion ] Effect of SB-318 on plasma IDUA activity [ Time Frame: Up to 36 months after the SB-318 infusion ] Effect of SB-318 on liver biopsy for measurement of IDUA [ Time Frame: Up to 36 months after the SB-318 infusion ] Effect of SB-318 on liver biopsy for measurement of glycosaminoglycans (GAG) [ Time Frame: Up to 36 months after the SB-318 infusion ] ___________________________________________________________________ open for recruitment imminent imho |
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Msg # | Subject | Author | Recs | Date Posted |
86808 | Re: MPS 1 updated april 26 but i dont see what changed ? | gomasna | 2 | 4/28/2017 11:13:25 AM |