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

GC Biopharma

Status and phase

Completed

Phase 3

Conditions

Hunterase

Hunter Syndrome

GC1111

Hunter Syndrome (MPS II)

MPS II

Treatments

Drug: Hunterase

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07344376

GC1111_P3_Ex

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Male

Volunteers

No Healthy Volunteers

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
Subject who received the treatment with another investigational product within 14 days prior to the start of study drug
Subject who plans to be treated with another investigational product during the study period
Subject who has history of tracheostomy, bone marrow transplant, or cord blood transplant
Any other inappropriate conditions for study participation at the investigator's discretion