Efficacy of corticosteroids combined with therapeutic plasma exchange in prolonged cholestasis following acute viral hepatitis: Randomised controlled trial - NIL

Department of Hepatology PGIMER0 个研究点目标入组 124 人开始时间: 2026年7月20日最近更新: 2026年8月3日

试验速览

暂无简介。

•Adults aged 18 or older.
•Confirmed diagnosis of AVH through compatible clinical signs and serological confirmation
•Prolonged cholestasis is defined by all of the following:
•At least 3 weeks since symptom onset
•Total bilirubin levels more than and equal to 5 mg per deciliter with direct fraction more than and equal to 50 percent
•Alkaline phosphatase more than and equal to 2 times the upper limit of normal or Gamma Glutamyl transferase more than and equal to 2 times the upper limit of normal, and or ongoing moderate to severe itching that is more than and equal to 5 times the on a 0 to 10 NRS.
•INR less than 1.5 and absence of hepatic encephalopathy that is no acute liver failure.
•Ability to provide informed consent.

•Preexisting liver disease including cirrhosis or chronic viral hepatitis.
•Clinical acute liver failure with INR more than and equal to1.5 with encephalopathy or acute on chronic liver failure.
•Uncontrolled sepsis or unstable hemodynamics or active gastrointestinal bleeding.
•Platelet count less than fifty thousand that cannot be corrected
•Fibrinogen less than hundred milligram per deci liter that cannot be corrected.
•Any contraindication to steroids or therapeutic plasma exchange including severe allergy to replacement fluids, heart failure etc.
•Immunosuppression or recent steroid use that is over ten mg prednisolone equivalent for more than seven days in the past month.
•Pregnancy or breastfeeding.
•Any other reasons deemed appropriate by the investigator that is inability to adhere to study protocols.

发起方

Department of Hepatology PGIMER