Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B
treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study
protocol for a randomized controlled trial.
Author(s): Qu J, Yu Z, Li Q, Chen Y, Xiang D, Tan L, Lei C, Bai W, Li H, Shang Q, Chen L, Hu
X, Lu W, Li Z, Chen D, Wang X, Zhang C, Xiao G, Qi X, Chen J, Zhou L, Chen G, Li
Y, Zeng Z, Rong G, Dong Z, Chen Y, Lou M, Wang C, Lu Y, Zhang C, Yang Y(1).
Affiliation(s): Author information:
(1)Center of Therapeutic Research for Liver Cancer, the 302 hospital of PLA, 100
Xisi Huan Middle Road, Beijing 100039, China. yongpingyang@hotmail.com.
Publication date & source: 2014, Trials. , 15(1):438
BACKGROUND: Chronic hepatitis B (CHB) can progress to cirrhosis, hepatocellular
carcinoma (HCC) and ultimately liver-related death. Although oral antiviral
therapy for patients with CHB reduces the risk of such complications, once
cirrhosis is established, the benefits of antiviral therapy are not robustly
demonstrated. According to traditional Chinese medicine (TCM), some Chinese
herbal medicines promote blood circulation and soften hard masses, and therefore
they may block and reverse hepatic fibrosis. The aim of this study is to evaluate
the effects of TCM tablets of the compound biejia ruangan (RGT) administered for
fibrosis, and entecavir (ETV), on the development of HCC in patients with CHB or
hepatitis B virus (HBV)-related compensated cirrhosis.
METHODS/DESIGN: This multicenter, centrally randomized, double-blind,
placebo-controlled, parallel-group study is planned to complete within 5 years.
For the study, 1,000 with CHB or HBV-related compensated cirrhosis are randomly
assigned in a 1:1 ratio to a treatment group (0.5 mg ETV once daily; 2 g RGT
three times daily) or a control group (0.5 mg ETV once daily; 2 g RGT dummy agent
three times daily). The primary end points are the development of HCC and
liver-related death. Secondary end points include disease progression and overall
survival.
DISCUSSION: Although antiviral therapy can achieve sustained suppression of HBV
replication, thereby preventing cirrhosis, patients with CHB treated with
nucleos(t)ide analogs (NUCs) retain a higher risk for HCC compared with patients
with inactive disease. Although previous clinical trials with RGT have confirmed
the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or
compensated cirrhosis, the long-term risk for HCC or disease progression in these
patients treated with combination of RGT and NUCs compared with NUCs alone is
unclear. Therefore, it is necessary to investigate the effects of the RGT
blockade and reversal of hepatic fibrosis on the development of HCC in patients
with CHB or HBV-related compensated cirrhosis in large, prospective, multicenter,
double-blind, randomized, controlled trials in China.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01965418. Date registered:
17 October 2013.
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