Hunter SyndromeNCT02044692
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
An observational study of Hunter Syndrome, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hunter Syndrome
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Jan 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hunter Syndrome(Mucopolysaccharidosis II) Patients
Who may be able to join
- Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
- Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
- Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.
Who cannot join
- Patients who have participated in any other blind clinical trials.
- Patient who cannot be tracked about safety.
- Patients who are judged disqualified to participate clinical trials by investigator for other causes.
Trial locations and contacts
1 site in 1 country.
Dong-Kyu Jin contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Dongkyu Jin
Dong Kyu Jin
About this study
Official title: The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients
The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients
- Conditions
- Hunter Syndrome
- Keywords
- Hunter syndrome, Mucopolysaccharidosis II, Hunterase
- Medical subject headings
- Mucopolysaccharidosis II
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event and adverse drug reaction.
Measured: Once a week up to 5years
Secondary outcomes (1)
Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.
Measured: Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Kyu Jin, Principal investigator, Samsung medical center, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044692
- Sponsor's protocol ID
- GC1111_OS
- Status last verified
- Jun 2014
- First submitted
- 19 Jan 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients
- ClinicalTrials.gov ID
- NCT02044692
- Acronym / sponsor ID
- GC1111_OS
- Conditions
- Hunter Syndrome
- Keywords
- Hunter syndrome, Mucopolysaccharidosis II, Hunterase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Jan 2014 (estimated)
- 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 long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hunter Syndrome(Mucopolysaccharidosis II) Patients
Key inclusion criteria (3 listed)
- Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
- Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
- Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.
Key exclusion criteria (3 listed)
- Patients who have participated in any other blind clinical trials.
- Patient who cannot be tracked about safety.
- Patients who are judged disqualified to participate clinical trials by investigator for other causes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse event and adverse drug reaction.
Time frame: Once a week up to 5years
1 secondary outcome
Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.
Time frame: Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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.
Dong-Kyu Jin contact
Dong-Kyu Jin principal investigator
Samsung medical center, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jun 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Kyu Jin (jindk.jin@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event and adverse drug reaction. (time frame: Once a week up to 5years). 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 20 Jun 2014.