Twinsburg, OHNCT05494593Now EnrollingIRB Ready

Hunter Syndrome Clinical Trial in Twinsburg, OH

Access cutting-edge hunter syndrome treatment through this clinical trial at a research site in Twinsburg. Study-provided care at no cost to qualified participants.

Sponsored by Takeda

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Expert Care in Twinsburg

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hunter syndrome treatment provided free

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Check if you qualify for this hunter syndrome clinical trial in Twinsburg, OH

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Why Participate?

  • No-Cost Study Care

  • Local to Twinsburg

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Twinsburg site if eligible
  4. 4Begin participation

About This Hunter Syndrome Study in Twinsburg

The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter syndrome. In this open label, single arm study, all participants will receive ELAPRASE treatment and a prophylactic ITR. Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. The prophylactic

Sponsor: Takeda

Who Can Participate

Inclusion Criteria

Participant is male.
Participant is ELAPRASE-naïve at study entry.
Participant must have a documented diagnosis of MPS II. The following combination will be accepted as diagnostic of MPS II:
Participant has a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of less than or equal to (\<=) 10 percent (%) of the lower limit of the normal range as measured in plasma, fibroblasts, or leukocytes (based on the reference laboratory's normal range). The participant has a normal enzyme activity level of at least 1 other sulfatase as measured in plasma, fibroblasts, or leukocytes (based on the reference laboratory's normal range).
Participant has a documented mutation in the IDS gene; additionally, participants must have a severe mutation (example, large deletion or complex gene rearrangement), which is predicted to lead to development of a persistent anti-idursulfase antibody response.
Participant will be less than (\<) 6 years of age at enrollment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Twinsburg?

Yes, this clinical trial (NCT05494593) has an active research site in Twinsburg, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hunter Syndrome Treatment Options in Twinsburg, OH

If you're searching for hunter syndrome treatment options in Twinsburg, OH, this clinical trial (NCT05494593) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Twinsburg research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hunter syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hunter syndrome clinical trials near you to find additional studies recruiting in your area.

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