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Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis

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ClinicalTrials.gov Identifier: NCT02659696
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Atsushi Tanaka, Teikyo University

Brief 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.

Condition or disease
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
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Evaluate the Efficacy of Nalfurafine Hydrochloride in Patients With Primary Biliary Cholangitis
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018





Primary Outcome Measures :
  1. Proportion of patients with improvement of pruritus measured by PBC-40 [ Time Frame: 3 months after administration of nalfurafine ]
    PBC-40 is a self-report questionnaire for the pruritus as well as health-related QOL in patients with PBC


Secondary Outcome Measures :
  1. Proportion of patients with improvement of overall health-related QOL measured by PBC-40 [ Time Frame: 3 months after administration of nalfurafine ]
    overall HRQOL is measured by SF-36


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659696


Locations
Japan
Teikyo University School of Medicine
Tokyo, Please Select, Japan, 1738605
Sponsors and Collaborators
Teikyo University
Investigators
Principal Investigator: Atsushi Tanaka, MD, PhD Teikyo University

Responsible Party: Atsushi Tanaka, Professor, Teikyo University
ClinicalTrials.gov Identifier: NCT02659696     History of Changes
Other Study ID Numbers: 15-037
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis