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

SexMALE

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
✕. 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

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

SexMALE

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
✕. 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