MY008211A Tablets for PNH Patients Naive to Complement Inhibitors
MY008211A tablets
+ Eculizumab Injection
Anemia+4
+ Anemia, Hemolytic
+ Bone Marrow Diseases
Treatment Study
Summary
Study start date: August 30, 2024
Actual date on which the first participant was enrolled.This clinical trial is focused on testing a new tablet called MY008211A for patients with a rare blood disorder known as Paroxysmal Nocturnal Hemoglobinuria (PNH). The study specifically targets individuals who have not previously received treatments known as complement inhibitors. The goal is to see if MY008211A is safe and effective compared to an existing treatment called eculizumab. This study is important because finding effective treatments can improve the quality of life for people with PNH and offer new options for those who have never tried these types of medications before. Participants in this study are randomly assigned to receive either the MY008211A tablets or eculizumab. The study is open-label, meaning both the participants and the researchers know which treatment is being administered. The main focus is to evaluate how well MY008211A works in comparison to eculizumab and to monitor any side effects or safety concerns. By comparing the two treatments, the study aims to gather valuable information on the effectiveness and safety of the new tablet, which could lead to better treatment options for PNH patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, ChinaOpen Chinese Academy of Medical Sciences Hematology Hospital in Google MapsPeking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China