Open-Label Extension Study to Assess GLM101 in PMM2-CDG Patients

Launched by GLYCOMINE, INC. · Oct 23, 2024

Keywords

ClinConnect Summary

This is a phase 2 open-label clinical study of GLM101 in patients with PMM2-CDG who have previously participated in a study of GLM101. This study is designed to monitor long-term safety and treatment effect of GLM101 and provided continued access to study treatment. Participants will continue weekly infusions of GLM101 at the same dose level they received in the previous study. Dose levels may be adjusted to lower doses or higher doses based on available data that demonstrates a change to be safe and tolerable. Participants will be asked to complete questionnaires to evaluate changes in ata...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to provide informed consent/assent and/or their legally authorized representative
• • Completed previous clinical study with GLM101
• • If female of childbearing potential, must not be pregnant and use a medically accepted method of contraception
• • If male and sexually active must agree to use a medically acceptable method of contraception
• • Willing ad able to adhere to study requirements described in the protocol
• Exclusion Criteria:
• • Has a condition that would compromise safety or compliance of participant or preclude participant completion of study
• • Has positive serum pregnancy test
• • Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, other study procedures, and study restrictions.