A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)

A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC) - A study to assess the safety and efficacy of rifampicin for progressive familial intrahepatic cholestasis (PFIC) and benign recurrent intrahepatic cholestasis (BRIC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017823

Enrollment

Registered

2015-06-05

Start date

2013-07-17

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

Progressive familial intrahepatic cholestasis Benign recurrent intrahepatic cholestasis

Interventions

Rifampicin (RFP, 10 mg/kg/day) are given for 4-8 weeks. When RFP is effective against cholestasis, RFP will be tapered 2.5mg/kg per a week and withdrawn after 4 weeks. When bilirubin level does not

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Progressive familial intrahepatic cholestasis or benign recurrent intrahepatic cholestasis patients. 2. Patients whose written informed consent has been obtained (from them or from their parents).

Exclusion criteria

Exclusion criteria: 1. Patients with past histories of hypersensitivity reaction against rifampicin. 2. Patients currently receiving medications that are known to interact with rifampicin (drug for HIV infection, voriconazole, pradicantel, tadalafil, telaprevir, or simeprevir etc.) 3. Patients with serious active bacterial infection as sepsis.

Design outcomes

Primary

Measure	Time frame
Serum bilirubin and total bile acid	—

Secondary

Measure	Time frame
1. Laboratory blood test data at 1, 2, 4, 8 and 12 weeks after treatment (CBC, AST, ALT, gGTP, TP, Alb, T.Chol, LDL-C, PT, APTT, Ca, P, ALP, TSH, fT4, analysis of bile acids in serum). 2. Frequency of adverse events.	—

Countries

Japan

Contacts

Public ContactShunsuke Kanno

Graduate School of Medical Sciences, Kyushu University Department of Pediatrics

kannos@pediatr.med.kyushu-u.ac.jp092-642-5421

Outcome results

None listed

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