+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial



Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial



Hepatology Research 48(6): 411-423



The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 060723272

Download citation: RISBibTeXText

PMID: 29235218

DOI: 10.1111/hepr.13045


Related references

A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. American Heart Journal 161(2): 261-268.E1-2, 2011

Phase II trial of vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer. A prospective, open label, non-controlled, multicenter phase II trial (to investigate efficacy and safety of this combination chemotherapy). Investigational new Drugs 27(2): 166-172, 2009

A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Research and Therapy 14(5): R217, 2012

Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. Journal of the Neurological Sciences 357(1-2): 192-197, 2015

Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI): Rationale and Design of AOSpine Phase III Multicenter Double-Blinded Randomized Controlled Trial. Spine Journal 14(11): S41-S42, 2014

Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI): Rationale and Design of AOSpine Phase III Multicenter Double Blinded Randomized Controlled Trial (RISCIS). Spine Journal 15(10): S265-S266, 2015

The efficacy and safety of herbal medicine BHH10 in postmenopausal women with osteoporosis: study protocol for a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Trials 19(1): 482, 2018

Efficacy and safety of mildronate for acute ischemic stroke: a randomized, double-blind, active-controlled phase II multicenter trial. Clinical Drug Investigation 33(10): 755-760, 2013

Efficacy and safety of recombinant human lymphotoxin-α derivative with cisplatin and fluorouracil in patients with metastatic esophageal squamous cell carcinoma: A randomized, multicenter, open-label, controlled, phase 2b trial. Cancer 123(20): 3986-3994, 2017

LICC: L-BLP25 in patients with colorectal carcinoma after curative resection of hepatic metastases: a randomized, placebo-controlled, multicenter, multinational, double-blinded phase II trial. Bmc Cancer 12(): 144-144, 2012

Comparison of the Clinical Efficacy and Safety of Subcutaneous Versus Oral Administration of Methotrexate in Patients With Active Rheumatoid Arthritis: Results of a Six-Month, Multicenter, Randomized, Double-Blind, Controlled, Phase IV Trial. Yearbook of Medicine 2009: 17-18, 2009

Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis and Rheumatism 58(1): 73-81, 2008

Comparison on the efficacy and safety of biphenyl dimethyl dicarboxylate and ursodeoxycholic acid in patients with abnormal alanine aminotransferase: multicenter, double-blinded, randomized, active-controlled clinical trial. Korean Journal of Gastroenterology 64(1): 31-39, 2014

Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leukemia and Lymphoma 57(6): 1291-1299, 2016

A Phase III, Multicenter, Randomized, Double-blind, Active Comparator Clinical Trial to Compare the Efficacy and Safety of Combination Therapy With Ezetimibe and Rosuvastatin Versus Rosuvastatin Monotherapy in Patients With Hypercholesterolemia: I-ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) Randomized Controlled Trial. Clinical Therapeutics 40(2): 226-241.E4, 2018