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Enzyme Replacement Therapy

Idursulfase-IT + Elaprase for Hunter Syndrome

Phase 2 & 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 10.4 years

Awards & highlights

Study Summary

This trial will investigate the safety of two treatments for Hunter Syndrome with cognitive impairment in children and adults who completed previous studies.

Who is the study for?

This trial is for children and adults with Hunter syndrome who have cognitive impairment and completed previous studies (HGT-HIT-046 or SHP609-302), showing benefits from idursulfase-IT. They must not be in other clinical trials, have intracranial hypertension, uncontrolled seizures, bleeding disorders, or severe hypertension.Check my eligibility

What is being tested?

The study extends prior research to further assess the safety of idursulfase-IT and Elaprase treatments in participants with Hunter syndrome and cognitive issues. Participants will continue receiving the same treatment as they did in earlier studies.See study design

What are the potential side effects?

While specific side effects are not listed here, the study aims to collect more safety data on idursulfase-IT and Elaprase which may include monitoring for any adverse reactions previously observed during ongoing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 10.4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 10.4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10.4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with AEs Related to Device Surgical Procedure

Number of Participants with AEs Related to IT Administration Process

Number of Participants with AEs Related to IV Elaprase Infusion

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Idursulfase-ITExperimental Treatment2 Interventions

Participants will receive idursulfase-IT once monthly and weekly IV infusions of elaprase at the dose used in previous studies (HGT-HIT-045/SHP609-302) via IDDD until benefit is no longer derived from the treatment, or treatment is no longer tolerable, or up to approximately 10.4 years.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,936 Total Patients Enrolled

4 Trials studying Hunter Syndrome

31 Patients Enrolled for Hunter Syndrome

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,264 Total Patients Enrolled

14 Trials studying Hunter Syndrome

1,784 Patients Enrolled for Hunter Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I have the qualifications necessary to take part in this medical research?

"A total of 8 participants are eligible to join this study, all of whom must have hunter syndrome and be between 3-19 years old."

Answered by AI

Are participants aged 45 or younger eligible for this research endeavor?

"The inclusion criteria for this trial requires participants to be between the ages of 3 and 19. There are 422 studies listed on clinicaltrials.gov targeting children under 18, while 1622 studies focus on adults aged 65 or older."

Answered by AI

How many sites are actively engaged in the management of this clinical trial?

"At this time, enrollment to the trial is open at 4 different sites: Vancouver, Toronto and Lyon Cedex amongst others. To reduce travelling costs associated with participation it may be beneficial to pick a centre which is close by."

Answered by AI

Are there any available opportunities of participation for this research?

"According to clinicaltrials.gov, this particular medical trial is not currently recruiting new participants. The study was originally posted on January 1st 2024 and has since been updated for the last time on September 21st 2023. Nevertheless, there are over two thousand other studies open for enrolment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment

2024. "Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06031259.