The Efficacy of Preventing Portal Hypertension and Treating Cirrhosis Decompensation Due to Hepatitis B with Fuzheng Huayu Tablets, Entecavir and Carvedilol: study protocol for a multicenter randomized controlled trial

Abstract Background Portal hypertension is an important pathological basis for the development of cirrhotic decompensation and its complications. The mechanism of its formation and development is complex, involving both increased intrahepatic resistance due to structural destruction of the liver and extrahepatic hyperdynamic circulation due to vasoactive substance disorders. However few drug has been provided values of primary prevention. Whether anti-liver fibrosis drugs would reduce the risk of portal hypertension was still not known. Methods/design: This is a non-blind, non-placebo-controlled, randomized, multicenter clinical trial. 192 chronic hepatitis B(CHB) patients with or without mild gastroesophageal varices in compensatory stage were enrolled for protocol A. Which the control group is given entecavir(ETV), and the experimental group is given Fuzheng Huayu Tablets(FZHY) and ETV. 184 CHB patients with moderate or severe gastroesophageal varices in compensatory stage were enrolled for protocol B. Which the control group is given ETV plus carvedilol(CDL), and the experimental group is given FZHY, ETV and CDL. Both protocols were carried out with 96w of treatment and 12w of follow-up. The primary outcome is the incidence of clinical event. The secondary outcome include: measurements of varicose veins, liver fibrosis and liver functions. Discussion This trial may carry out the effects of anti-liver fibrosis drugs(FZHY) on preventing portal hypertension or treating cirrhosis decompensation due to CHB. Trial registration: Clinical Trials.gov, ID: NCT 02945982. Registered on October 26, 2016.