A Phase 1 interventional study of EPEG in Beta-Thalassemia, sponsored by Prolong Pharmaceuticals. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-25.
Sponsored by Prolong Pharmaceuticals · Phase 1, Interventional, and Treatment
Among 24 studies in beta-Thalassemia with a site in Thailand — 2 open to participants now, 6 under way, 3 of them phase 3. beta-Thalassemia · Thailand.
Among the 24 studies in beta-Thalassemia with a site in Thailand, this one is the 21st largest by enrollment of the 22 interventional ones that give a count, is one of 3 that started in 2017, is one of 3 in phase 1, and was the 12th registered.
294 studies on the registry are indexed under beta-Thalassemia; 69 are open to participants now.
Browse beta-Thalassemia studies →2 of the 24 studies in beta-Thalassemia with a site in Thailand are open now. Recruiting first, the newest first:
Celgene · Sites in Thailand, United States, China and 6 more countries
Ages 6–17
Celgene · Sites in Thailand, United States, Australia and 19 more countries
Ages 18+
A study can be open while its sites in Thailand have not opened yet or have stopped. Only those recruiting at a site in Thailand →
Of the 43 beta-Thalassemia studies recruiting now, 10 (23%) set no upper age limit and 31 (72%) stop at 75 or younger; 34 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 14 · Phase 3 5
First in 2008; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 40 across 208 interventional studies indexed under beta-Thalassemia.
Median enrollment 30 across the 22 interventional studies, 83 across the 2 observational. Of the 17 that completed or were terminated, 8 (47%) have results posted.
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23 of 24 have an industry lead sponsor. The 10 most frequent:
Prolong Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Prolong Pharmaceuticals has 1 study filed under beta-Thalassemia — fewer than ten, so there is no comparison to draw.
1 of the studies in beta-Thalassemia with a site in Thailand that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06421636Regeneron PharmaceuticalsA Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body | 2026-12-03 |
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Among the 24 studies in beta-Thalassemia with a site in Thailand, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
Following the provision of informed consent, screening visit procedures to be performed will include: a detailed medical history (including concomitant medications), physical exam, vital signs (non-invasive systolic and diastolic arterial blood pressure, heart rate, and respiratory rate, temperature, and oxygen saturation by pulse oximetry,), laboratory testing of blood samples collections for safety (hematology and chemistry), and urinalysis (dipstick and microscopy, if necessary). A serum pregnancy test for all female patients (of child-bearing potential) will be measured during the Screening Visit. Urine pregnancy test for all female patients (of child-bearing potential) will be measured at each dosing visit prior to dosing.
Eligible patients will receive either subcutaneous injection of EPEG (0.9 µg/kg, 1.2 µg/kg, and 1.5 µg/kg,) for four weeks followed by follow up for 5-6 weeks after 4th dose of IP.
Vital signs will be recorded for study documentation at 1 hour after dosing and at discharge of the day (to occur 2 hours after the time of dosing). All patients will receive standard of care as per investigative site standard practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following medical conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Four weekly subcutaneous injections of 0.9 µg/kg EPEG
Drug: EPEG
Four weekly subcutaneous injections of 1.2 µg/kg EPEG
Drug: EPEG
Four weekly subcutaneous injections of 1.5 µg/kg EPEG
Drug: EPEG
(Pegylated erythropoeitin)
Number of participants in each treatment arm with abnormal laboratory values and/or adverse events that are related to treatment.
Safety of treatment as determined by changes in vital signs, chest X-Ray, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Time frame: 60 days
Change in the Hemoglobin from Baseline to the Final Visit
Time frame: 60 Days
A mean increase in Hematocrit (Hct) from Baseline to the Final Visit
Time frame: 60 Days
A mean increase in reticulocyte count from Baseline to the Final Visit
Time frame: 60 Days
Change in clinical signs and symptoms of β-NTDT from Baseline to the Final Visit
Time frame: 60 Days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Sep 2017, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etoposide
Prolong Pharmaceuticals