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Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)

NCT00069641 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-06-10

Study results available
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Summary

The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.

Conditions

  • Mucopolysaccharidosis II

Interventions

BIOLOGICAL

Iduronate-2-sulfatase enzyme replacement therapy

Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.

BIOLOGICAL

iduronate-2-sulfatase enzyme replacement therapy

Patients will receive every other week infusions of idursulfase at a dose of 0.5 mg/kg.

BIOLOGICAL

Placebo

Patients will receive weekly infusions of placebo.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-18
Primary Completion
2005-03-16
Completion
2005-03-16

Countries

  • United States
  • Brazil
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00069641 on ClinicalTrials.gov