Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
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|ClinicalTrials.gov Identifier: NCT02659696|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : October 12, 2017
|Condition or disease|
|Primary Biliary Cirrhosis|
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|
|Estimated Enrollment :||200 participants|
|Official Title:||An Observational Study to Evaluate the Efficacy of Nalfurafine Hydrochloride in Patients With Primary Biliary Cholangitis|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
- 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
- Proportion of patients with improvement of overall health-related QOL measured by PBC-40 [ Time Frame: 3 months after administration of nalfurafine ]
Biospecimen Retention: Samples Without DNA
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
|Teikyo University School of Medicine|
|Tokyo, Please Select, Japan, 1738605|
|Principal Investigator:||Atsushi Tanaka, MD, PhD||Teikyo University|