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An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.

NCT02350816 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-06-11

Study results available
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Summary

This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy of the study drug.

Conditions

  • Sanfilippo Syndrome
  • Mucopolysaccharidosis (MPS)

Interventions

DRUG

HGT-1410

HGT-1410 administered according to Patient Group assignment.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-08
Primary Completion
2019-04-12
Completion
2019-04-12

Countries

  • United States
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350816 on ClinicalTrials.gov