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 range18 Years – 65 Years

SexALL

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:
✕. 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

What they're measuring

Number of participants in each treatment arm with abnormal laboratory values and/or adverse events that are related to treatment.

Timeframe: 60 days

Trial details

NCT IDNCT02950857

SponsorProlong Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-27

View on ClinicalTrials.gov More Beta-Thalassemia trials