A Study of EPEG in Beta Thalassemia Patients (NCT02950857) | Clinical Trial Compass
CompletedPhase 1
A Study of EPEG in Beta Thalassemia Patients
Thailand6 participantsStarted 2017-06-28
Plain-language summary
An open-label study in which 6 patients will receive once-weekly subcutaneous injections of EPEG for 4 weeks. Final visit will occur 60 days after study entry
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female
. Age 18 - 65 years of age
. Confirmed diagnosis of Non-Transfusion Dependent β-thalassemia (β-NTDT)
. Hemoglobin 6.0-10.0 g/dL
. Signed and dated informed written consent by the subject
. Able to receive subcutaneous injections of study drug
. Female patients must be non-lactating
. Female patients of reproductive potential must have a negative serum pregnancy (β-HCG) test at screening.
Exclusion criteria
. In the judgment of the investigator the patient is not a good candidate for the study
. Blood transfusion within the last 30 days
. Any of the following medical conditions:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants in each treatment arm with abnormal laboratory values and/or adverse events that are related to treatment.
. Severe kidney insufficiency, defined as use of hemodialysis or serum creatinine at levels greater than 2.5 mg/dL at the time of screening
. Cardiac disease with adjustment of cardiac medications in the 60 days before study entry
. Symptomatic coronary artery disease, as indicated by a history of chest pain, angina, claudication, or surgery to treat coronary artery disease in the 1 year before study entry
. Stroke, defined as a new focal neurological deficit lasting more than 24 hours in the 45 days before study entry
. New diagnosis of pulmonary embolism by ventilation-perfusion scan, angiography, or any other technique in the 90 days before study entry