Phase 4 study of nalfurafine hydrochloride for pruritus in patients with PBC

Phase 4 study of nalfurafine hydrochloride for pruritus in patients with PBC - Nalfurafine for pruritus in PBC

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019296

Enrollment

200

Registered

2015-10-09

Start date

2015-10-01

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

primary biliary cholangitis, primary sclerosing cholangitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with PBC or PSC, who were indicated for nalfurafine treatment by physician.

Exclusion criteria

Exclusion criteria: patients with a history of allergy to nalfurafine, patients with severe liver impairment (Child-Pugh grade C), patients with mild pruritus, and patients who were not indicated for nalfurafine treatment.

Design outcomes

Primary

Measure	Time frame
improvement of pruritus and quality of life at 3 months after nalfurafine administration. Pruritus and QOL will be judged by PBC-40.	—

Secondary

Measure	Time frame
liver function tests, serum autaxin levels	—

Countries

Japan

Contacts

Public ContactAtsushi Tanaka

Teikyo University School of Medicine Department of Medicine

a-tanaka@med.teikyo-u.ac.jp03-3064-1211

Outcome results