CompletedPhase 3

An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)

South Korea30 participantsStarted 2018-05-23

Plain-language summary

The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients who received Hunterase for more than 6 months

Who can participate

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject diagnosed with Hunter syndrome (MPS II) who completed activities at the EOS visit (Visit 54) in the GC1111\_P3 study
. (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
. (Subjects who did not participate in the GC1111\_P3 study) Males aged ≥ 5
. Informed consent form voluntarily signed by the subject or by a legally acceptable representative
. Subject who agrees to use contraception

Exclusion criteria

. Subject with hypersensitivity to any of the ingredients of the investigational product
. Subject impossible to perform follow-up observation of the safety

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Laboratory tests (CBC, Chemistry, Urinanalysis)

Timeframe: Every visit until 12months

Physical examination

Timeframe: Every visit until 12months

Adverse Event

Timeframe: Every visit until 12months

Electrocardiography

Timeframe: Every 6 months until 12months

Trial details

NCT IDNCT07344376

SponsorGC Biopharma Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More MPS II trials

Who can participate

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject diagnosed with Hunter syndrome (MPS II) who completed activities at the EOS visit (Visit 54) in the GC1111\_P3 study
. (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
. (Subjects who did not participate in the GC1111\_P3 study) Males aged ≥ 5
. Informed consent form voluntarily signed by the subject or by a legally acceptable representative
. Subject who agrees to use contraception

Exclusion criteria

. Subject with hypersensitivity to any of the ingredients of the investigational product
. Subject impossible to perform follow-up observation of the safety