A Phase 3 interventional study of GC1111 and Comparator in Hunter Syndrome, sponsored by Green Cross Corporation. Completed at 1 site in Korea, Republic of. Open to male participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Green Cross Corporation · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
77 studies on the registry are indexed under Mucopolysaccharidosis II; 8 are open to participants now.
This study's enrollment of 32 is above the median of 22 across 48 interventional studies indexed under Mucopolysaccharidosis II.
Browse Mucopolysaccharidosis II studies →Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In part 1, all participants who randomized into GC1111 arm should receive the GC1111 for 52 weeks. In part 2, all enrolled participants should receive the GC1111 for 52 weeks.
Combination Product: GC1111
In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks.
Combination Product: Comparator
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
Change in 6-MWT
Time frame: at Week 53 from baseline
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Idursulfase