Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659696
• Other study ID #: 15-037
• Status: Completed
• First received: December 19, 2015
• Last updated: April 24, 2018
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Teikyo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Locations

Country	Name	City	State
Japan	Teikyo University School of Medicine	Tokyo	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Teikyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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