NCT02659696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

December 19, 2015

Last Update Submit

April 24, 2018

Conditions

Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of patients with improvement of overall health-related QOL measured by PBC-40

    3 months after administration of nalfurafine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teikyo University School of Medicine

Tokyo, Please Select, 1738605, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Atsushi Tanaka, MD, PhD

    Teikyo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2015

First Posted

January 20, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)