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Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies

NCT05935202 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-12-26

No results posted yet for this study

Summary

This is a prospective exploratory multicentre pilot study designed to study the safety and efficacy of mitapivat in RBC membranopathies and CDAII

Conditions

  • Hereditary Red Blood Cell Disorder (Disorder)

Interventions

DRUG

Mitapivat sulfate

Subjects enrolled Maximum dose: will receive Mitapivat during 56 weeks Starting dose: 50 mg BD Maximum dose: 100 mg BD

Sponsors & Collaborators

  • EuroBloodNet Association

    lead OTHER

Principal Investigators

  • Andreas Glenthøj, MD/PhD · Rigshospitalet, Denmark

  • Pierre FENAUX, MD/PhD · Hôpital Saint Louis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-07-15
Completion
2026-12-15

Countries

  • Denmark
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935202 on ClinicalTrials.gov