Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis

An Observational Study to Evaluate the Efficacy of Nalfurafine Hydrochloride in Patients With Primary Biliary Cholangitis

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cirrhosis

Detailed Description

Primary biliary cholangitis (PBC, formally known as primary biliary cirrhosis) is a chronic cholestatic liver disease. Taking advantage of ursodeoxycholic acid (UDCA), the outcome of patients with PBC has been improved, comparable to those in general population. However, pruritus, which is often a persisting and annoying symptom, may decrease the quality of life (QOL) of patients with PBC. Although anti-histamines are administered for this the efficacy is limited, and no drugs which was clearly proved to be effective for suppressing pruritus have been developed worldwide.

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in January 2009 approved for pruritus in patients with renal failure and under hemodialysis. A phase 3 trial of nalfurafine hydrochloride for pruritus in patients with chronic liver diseases was completed, indicating the efficacy as well as safety was confirmed. Therefore, in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. However, only 59 patients with PBC were included and therefore it is still unclear whether nalfurafine chloride is effective in all PBC patients or a part of them, whether the effect of this drug depends on coadministered drugs or other complications, or whether this drug may improve QOL overall in patients with PBC.

In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC, to answer the clinical questions described above. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Japan
  • Please Select
    • Tokyo, Please Select, Japan, 1738605
      • Teikyo University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with PBC, who complained of moderate or severe pruritus, and decided by physician to be administered nalfurafine hydrochloride

Description

Inclusion criteria:

• Clinical diagnosis of PBC
• Complain of moderate or severe pruritus
• Decided by physician to be administered nalfurafine hydrochloride

Exclusion criteria

• Severe liver damage (Child-Pugh grade C)
• Allergic to nalfurafine hydrochloride
• With no or mild pruritus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with improvement of pruritus measured by PBC-40	PBC-40 is a self-report questionnaire for the pruritus as well as health-related QOL in patients with PBC	3 months after administration of nalfurafine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with improvement of overall health-related QOL measured by PBC-40	overall HRQOL is measured by SF-36	3 months after administration of nalfurafine

Collaborators and Investigators

• Sponsor: Teikyo University
• Investigators: Principal Investigator: Atsushi Tanaka, MD, PhD, Teikyo University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: 15-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO