A prospective, open, randomized study to evaluate the efficacy and safety of 20% HBC salmon protein hydrolyate in whey protein isolate (Whey Tech Pro Gold â?¢) powder to improve hemoglobin and serum ferritin in anaemic patients - Nil

Hofseth Biocare AS0 个研究点目标入组 48 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Red blood cell transfusions within the past 3 months.
•2. Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated
•3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months.
•4. Active infection defined as symptomatic, requiring active treatment (prophylaxis
•allowed) or hospitalized for > 24 hours primarily for infection within the past
•5. Uncontrolled hypertension defined as diastolic blood pressure > 100 mm Hg or
•systolic blood pressure > 160 mm Hg on 2 separate occasions during screening
•6. Other primary uncorrected cause for anemia including:
•a. Known active inflammatory disease including autoimmune diseases (e.g.,
•systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue
•disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia
•rheumatica, temporal artheritis).
•b. Chronic active infection (e.g., HIV, viral hepatitis).
•c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia,
•prostatitis).
•d. Receipt of immunosuppressive therapy in the past 2 years.
•e. Any cancer (aside from nonmelanoma skin cancer) in the past 2 years or on
•therapy for cancer.
•7. Elevated AST or ALT >= 2x upper limit of normal.
•8. Total bilirubin > 1.5 mg/dL.
•9. Use of any other experimental drug or therapy within 28 days of initial screening
•10. Dementia defined as the inability to independently provide informed consent.
•11. Recent history of Gastroin test bleed.

发起方

Hofseth Biocare AS