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Completed

NCT Number: NCT03920540

A Study of GC1111 in Hunter Syndrom Patients

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

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Key information

Conditions

Hunter Syndrome Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Death Death, Sudden Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Infant Death Intellectual Disability Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis II Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases Sudden Infant Death X-Linked Intellectual Disability

Age range

5 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Samsug Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

GC1111

Combination Product

GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

Comparator

Combination Product

Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.

Primary outcomes

  1. Change in 6-MWT

    Time frame: at Week 53 from baseline

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2019
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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