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Sucraid (sacrosidase) Oral Solution 8500 IU/mL for Sucrose-Isomaltase Deficiency

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Sucrose-Isomaltase Deficiency+2 MoreSucraid (sacrosidase) Oral Solution 8500 IU/mL - Biological
Eligibility
6 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the response of 1100 children with CSID to a 7-day treatment of Sucraid. It will also look at the relationship between known CSID mutations and sucrase activity levels.

Eligible Conditions
  • Congenital Sucrase-Isomaltase Deficiency
  • Sucrose-Isomaltase Deficiency

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
BBP-671
1
AAV2-hAADC
1
RP-L301

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 2 years

Post 7-day run-in period plus 7-day treatment period.
Effects of Sucraid® treatment on gastrointestinal symptoms in subjects with low, moderate, and normal disaccharidase assay sucrase levels from an esophagogastroduodenoscopy (EGD).
Up to 2 years
Explore the relationship between known genetic CSID mutations and sucrase activities via (EGD) disaccharidase assay (low, moderate, and normal).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
BBP-671
1
AAV2-hAADC
1
RP-L301

Trial Design

1 Treatment Group

Single Arm Open Labeled Commercial Sucraid
1 of 1

Experimental Treatment

1100 Total Participants · 1 Treatment Group

Primary Treatment: Sucraid (sacrosidase) Oral Solution 8500 IU/mL · No Placebo Group · Phase 4

Single Arm Open Labeled Commercial Sucraid
Biological
Experimental Group · 1 Intervention: Sucraid (sacrosidase) Oral Solution 8500 IU/mL · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

QOL Medical, LLCLead Sponsor
5 Previous Clinical Trials
299 Total Patients Enrolled
Weng Tao, M.D., Ph. DPrincipal InvestigatorQOL Medical
2 Previous Clinical Trials
236 Total Patients Enrolled

Eligibility Criteria

Age 6 - 17 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with documented sucrase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation.
You have a DAS >55.
You must provide informed consent/assent prior to any study procedures being performed.
You must be able to read or understand the English language.
References

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