Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study

Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study - Nalfurafine hydrochloride and chronic liver diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028161

Enrollment

Registered

2017-07-12

Start date

2017-08-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic liver disease patients with refractory pruritus

Interventions

Study drug (1 cap per day) will be prescribed orally after dinner or before going to bed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hepatic inflammation persisting for at least 6 months Patients who were not expected to show rapid changes in the general status Patients whose pruritus was regarded as to be uncontrollable by medicines within 6 months before IC.

Exclusion criteria

Exclusion criteria: (1)Patients with past history for hypersensitivity for the ingredients of testing drugs. (2)Female patients with pregnancy or suspected of being pregnant, or those desiring pregnancy during study period. (3)Lactating female patients (4)Patients who were judged to be inappropriate for the study subjects

Design outcomes

Primary

Measure	Time frame
Sleep related variables using actigram	—

Countries

Japan

Contacts

Public Contactkazunori Yoh

Hyogo college of medicine Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine

mm2wintwin@ybb.ne.jp0798-45-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026