Primary Biliary CirrhosisNCT02659696
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
An observational study of Primary Biliary Cirrhosis, run by Teikyo University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cirrhosis
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2015to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PBC, who complained of moderate or severe pruritus, and decided by physician to be administered nalfurafine hydrochloride
Who may be able to join
- Clinical diagnosis of PBC
- Complain of moderate or severe pruritus
- Decided by physician to be administered nalfurafine hydrochloride
Who cannot join
- Severe liver damage (Child-Pugh grade C)
- Allergic to nalfurafine hydrochloride
- With no or mild pruritus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Biliary Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Biliary
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after administration of nalfurafine
Secondary outcomes (1)
Proportion of patients with improvement of overall health-related QOL measured by PBC-40
overall HRQOL is measured by SF-36
Measured: 3 months after administration of nalfurafine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atsushi Tanaka, Teikyo University
- Investigators
- Atsushi Tanaka, MD, PhD, Principal investigator, Teikyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659696
- Sponsor's protocol ID
- 15-037
- Status last verified
- Apr 2018
- First submitted
- 19 Dec 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Efficacy of Nalfurafine Hydrochloride in Patients With Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT02659696
- Acronym / sponsor ID
- 15-037
- Conditions
- Primary Biliary Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Teikyo UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PBC, who complained of moderate or severe pruritus, and decided by physician to be administered nalfurafine hydrochloride
Key inclusion criteria (3 listed)
- Clinical diagnosis of PBC
- Complain of moderate or severe pruritus
- Decided by physician to be administered nalfurafine hydrochloride
Key exclusion criteria (3 listed)
- Severe liver damage (Child-Pugh grade C)
- Allergic to nalfurafine hydrochloride
- With no or mild pruritus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Proportion of patients with improvement of overall health-related QOL measured by PBC-40
Time frame: 3 months after administration of nalfurafine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Primary Biliary Cirrhosis
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsushi Tanaka, MD, PhD principal investigator
Teikyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cirrhosis, run by Teikyo University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with improvement of pruritus measured by PBC-40 (time frame: 3 months after administration of nalfurafine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.