[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Incepta Pharmaceuticals Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100594917","phase-3-pk-pd-safety-and-immunogenicity-study-of-erythropoietin-of-incepta-pharmaceuticals-ltd-with-eprex-janssen-cilag-100594917",false,"NCT07025681","PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).","Randomized, Double-blinded, Two-treatment, Two-periods, Single-dose, Crossover, PK, PD, Safety, and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex of Janssen-Cilag Ltd in Healthy Adult Subjects","Inclusion Criteria:\n\n* • Age ≥ 18 years.\n\n  * BMI of 18.0-30.0kg\u002Fm2.\n  * Voluntarily participants who agree to observe the precautions in writing after receiving a complete explanation of this trial.\n  * Willingness and ability to undertake all scheduled visits and assessments.\n  * Subject who have no evidence of underlying disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study.\n  * Subjects whose screening laboratory values are within normal limits or considered by the Investigator to be of no clinical significance.\n  * Non-smokers, ex-smokers and light smokers can be included in the study. \"Light smokers are defined as someone smoking \\\u003C 10 cigarettes per day, ex-smokers as someone who completely stopped smoking for at least 03 months.\n  * No alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year.\n  * Subjects should not have consumed grape fruit juice or its products 72 hours before dosing and throughout the study periods.\n  * For Female Subjects:\n\n    1. Subjects having negative urine pregnancy test.\n    2. Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.\n    3. Postmenopausal for more than 1 year.\n    4. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).\n\nExclusion Criteria:\n\n* • Subjects with any previous exposure to erythropoiesis stimulating agents.\n\n  * History of clinically significant illness related to liver (including viral hepatitis), kidney, nervous system, immune system, respiratory system, endocrine system, cardiovascular system, blood system and tumor as well as mental illness (mood disorder, obsessive-compulsive disorder, etc.)\n  * Hypersensitivity or clinically significant hypersensitivity to the drug (e.g. aspirin, antibiotics, etc.)\n  * Those whose results meet more than one of the followings in the screening including re-test; Hemoglobin level below 12g\u002FdL or over 17g\u002FdL, Ferritin level below 21.8ng\u002FmL, Transferrin level below 190mg\u002FdL, Reticulocyte level \\>2.5%, erythrocytes level \\> 5.2x 106\u002Fmm3, platelets or serum potassium level over normal range.\n  * Positive on the HIV antibody, HBsAg, HCV (Hepatitis C Virus) antibody tests.\n  * Those whose vital signs measured in sitting position after resting over 3 minutes meet more than one of the following; Systolic BP below 90mmHg or over 160mmHg, Diastolic BP below 50mmHg or over 100mmHg, Pulse rate over 100.\n  * Those who received the following diagnosis within 6 months prior to the screening; Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all kinds), Chronic or uncontrollable inflammatory diseases (e.g., rheumatoid arthritis, systemic erythematosus)\n  * Those who participated other clinical trials and was administered other drugs within 3 months prior to the scheduled dose.\n  * Those who bled over 400mL or donated blood within 8 weeks prior to the scheduled first dose.\n  * Those who are considered inappropriate for the trial by the trial investigator based on the result of clinical laboratory test or due to other reasons.\n  * Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.",true,"ALL","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Erythropoietin, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. Erythropoietin binds to the surface receptor of erythroid precursor cells and activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human erythropoietin is a substitute for the deficiency observed in CKD, therapy of anemia often involves many other issues such as Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin \\> 10 to \\\u003C 13 g\u002FdL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients are also needed to be considered in order to effectively correct anemia, reduce costs and minimize side effects.",[27],"Healthy",[29,30,31,32],"Erythropoietin","cross over","Eprex","Double blinded","RECRUITING","2025-06-15",{"date":36,"type":37},"2025-06-17","ACTUAL",{"date":39,"type":37},"2025-04-24",{"date":41,"type":21},"2025-12-31",{"name":43,"class":44},"Incepta Pharmaceuticals Ltd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100539559","phase-3-a-efficacy-and-safety-study-of-ranibizumab-10mgml-injection-incepta-in-patients-with-diabetic-macular-edema-100539559","NCT06305416","A Efficacy and Safety Study of Ranibizumab 10mg\u002Fml Injection (Incepta) in Patients With Diabetic Macular Edema","Randomized, Double-blind, Parallel, Active Controlled Study to Compare Efficacy & Safety Between Ranibizumab 10mg\u002Fml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection","Inclusion Criteria:\n\n1. Ages Eligible for Study: ≥ 18 Years\n2. Ability to provide written informed consent and comply with study assessments for the full duration of the study\n3. Diagnosis of diabetes mellitus (type 1 or 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: Laboratory reports that prove DM of patient or current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemic agent for the treatment of diabetes.\n4. Clinical evidence of retinal thickening due to macular edema involving the center of the macula (can be associated with diabetic retinopathy)\n5. Central diabetic macular edema present on clinical examination and OCT testing with central 1mm sub field thickness greater than 300 microns as measured on -OCT\n6. Visual acuity score greater than or equal to 19 letters (20\u002F400) and less than or equal to 73 letters (20\u002F40) by the ETDRS\u002F Snellen chart visual acuity protocol\n7. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography\n8. Willingness and ability to undertake all scheduled visits and assessments\n\nExclusion Criteria:\n\n1. Prior treatment with any Intravitreal drug, Bevacizumab, verteporfin or photodynamic therapy (except for extra foveal laser photocoagulation) in the study eye within past 3 months before study entry\n2. Laser photocoagulation in the study eye within 1 month before study entry\n3. Participation in another ocular investigation or trial simultaneously\n4. Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.\n5. Blood pressure \\> 160\u002F100 mmHg (systolic above 160 or diastolic above 100) and Random Blood Sugar (RBS) ≥ 12 mmol\u002FL and\u002F or HbA1c ≥ 7.5%\n6. Evidence of vitreoretinal interface abnormality and optic nerve disease after ocular exam or OCT that may be contributing to the macular edema\n7. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that could contribute to a loss of best corrected visual acuity over the study period (e.g. cataract that might decrease the vision by 3 or more lines, uncontrolled glaucoma, uveitis, previous corneal transplant etc.). The decision regarding exclusion is to be based on the opinion of the investigator.\n8. An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of sub retinal fibrosis or geographic atrophy).\n9. Presence of suspected ocular or periocular infections, another ocular condition that may affect the visual acuity or macular edema during the course of the study (uveitis, Irvine-Gas)\n10. Vitreous hemorrhage preventing visualization of retina\n11. History of vitreous surgery, cataract surgery, YAG capsulotomy in the study eye within last 3 months of enrolment\n12. Visual acuity \\\u003C20\u002F400 in the fellow eye\n13. Known hypersensitivity to Ranibizumab or any of the components of study medication\n14. History of cerebral vascular accident or myocardial infarction within past 3 months.\n15. Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.\n16. Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine\u002F hydroxychloroquine, tamoxifen, phenothiazine, vigabatrin and ethambutol, and such medications will not be allowed during the study period.",{"count":54,"type":21},70,[24],"Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema.\n\nDiabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus.\n\nThe use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid.",[58,59,60,61,62,63],"Diabetic Macular Edema","Diabetic Retinopathy","Macular Edema","Macular Degeneration","Retinal Disease","Retinal Degeneration",[65,66,67,68,69],"Ranibizumab","Efficacy","Diabetes","Retina","Edema","2025-06-03",{"date":72,"type":37},"2025-06-06",{"date":74,"type":37},"2024-03-30",{"date":76,"type":21},"2025-12",{"name":43,"class":44},""]