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Hunterase extended trial shows promise for managing hunter syndrome

NCT ID NCT07344376

Disease control Sponsor: GC Biopharma Corp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety and effectiveness of Hunterase (idursulfase beta) in 30 people with Hunter syndrome over about one year. Participants had either completed a previous phase 3 study or had used Hunterase for at least six months. The goal was to monitor side effects and track changes in walking ability and urine markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hunterase (idursulfase beta)
What this could lead to
If successful, this could confirm that long-term use of Hunterase is safe and helps manage symptoms of Hunter syndrome.
What could go wrong
This is an extension study with only 30 participants, so results may not apply to everyone. It focuses on safety, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

30 people

The number who actually took part.

Started

May 2018

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject diagnosed with Hunter syndrome (MPS II) who completed activities at the EOS visit (Visit 54) in the GC1111\_P3 study 2. (Subject who did not participate in the GC1111\_P3 study) Subject diagnosed with Hunter syndrome (MPS II) who received Hunterase for more than 6 months 3. (Subjects who did not participate in the GC1111\_P3 study) Males aged ≥ 5 4. Informed consent form voluntarily signed by the subject or by a legally acceptable representative 5. Subject who agrees to use contraception Exclusion Criteria: 1. Subject with hypersensitivity to any of the ingredients of the investigational product 2. Subject impossible to perform follow-up observation of the safety 3. Subject who received the treatment with another investigational product within 14 days prior to the start of study drug 4. Subject who plans to be treated with another investigational product during the study period 5. Subject who has history of tracheostomy, bone marrow transplant, or cord blood transplant 6. Any other inappropriate conditions for study participation at the investigator's discretion

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Conditions

The condition(s) this trial relates to.

mucopolysaccharidosis II, dog mucopolysaccharidosis type 2 Sudden Infant Death

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GC1111 Hunter syndrome Hunter syndrome (MPS ii) Hunterase MPS ii

Contacts and locations

Locations

  • Samsung Medical Center

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.