Hunter SyndromePhase 3NCT03920540
A Study of GC1111 in Hunter Syndrom Patients
A Phase 3 study testing GC1111 and Comparator in people with Hunter Syndrome, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients Read more about this study
- Who is it for?
- Ages 5 years and older, men only
- Conditions the study is for
- Hunter Syndrome
- What is being tested?
- GC1111 and Comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2017to 15 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with Hunter syndrome
- Male at the age of ≥ 5
- Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
- Voluntarily signed written informed consent to participation in this study
- Consent to contraception
Who cannot join
- Prior treatment with iduronate-2-sulfatase ERT
- History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
- Known hypersensitivity reactions to any of the components of the invetigational product
- Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
- Unable to perform 6-MWT.
- Female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Conditions
- Hunter Syndrome
- Being tested
- GC1111, Comparator
- Keywords
- GC1111, Mucopolysaccharidosis II, MPS II, idursulfase-beta, IDS
- Medical subject headings
- Mucopolysaccharidosis II, Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC1111Combination product
GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
ComparatorCombination product
Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| GC1111 | Experimental | 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. Receives: Combination Product: GC1111 |
| Comparator (Part 1) | Active comparator | In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks. Receives: Combination Product: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-MWT
Measured: at Week 53 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start9 Mar 2017
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hunter SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DongKyu Jin, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920540
- Sponsor's protocol ID
- GC1111_P3
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2019
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
- ClinicalTrials.gov ID
- NCT03920540
- Acronym / sponsor ID
- GC1111_P3
- Conditions
- Hunter Syndrome
- Keywords
- GC1111, Mucopolysaccharidosis II, MPS II, idursulfase-beta, IDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC1111 | Experimental | Combination Product: GC1111In 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. |
| Comparator (Part 1) | Active comparator | Combination Product: ComparatorIn Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks. |
Who may qualify
- Ages
- 5 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Hunter syndrome
- Male at the age of ≥ 5
- Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
- Voluntarily signed written informed consent to participation in this study
- Consent to contraception
Key exclusion criteria (6 listed)
- Prior treatment with iduronate-2-sulfatase ERT
- History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
- Known hypersensitivity reactions to any of the components of the invetigational product
- Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
- Unable to perform 6-MWT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC1111GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion. | Combination product | GC1111 |
| ComparatorComparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion. | Combination product | Comparator (Part 1) |
Primary outcome
Change in 6-MWT
Time frame: at Week 53 from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hunter Syndrome
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Active, not recruitingPhase 3
A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
Mucopolysaccharidosis II
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
Active, not recruitingPhase 2/3
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Mucopolysaccharidosis II
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DongKyu Jin, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC1111 and Comparator in people with Hunter Syndrome, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-MWT (time frame: at Week 53 from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.