Efficacy and safety study of dimethyl fumarate in adjuvant therapy for biliary atresia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035667

Enrollment

Unknown

Registered

2020-08-16

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

Biliary Atresia

Interventions

control group:Take a placebo

Experimental group:Take dimethyl fumarate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biliary atresia is clearly diagnosed; 2. Kasai surgery is underwent within 90 days.

Exclusion criteria

Exclusion criteria: 1. Patients with biliary atresia who will undergo surgery over 90 days; 2. Patients with confirmed biliary atresia but not undergo Kasai surgery; 3. Patients with life-threatening complications.

Design outcomes

Primary

Measure	Time frame
Number of peripheral blood lymphocytes, relative proportions of Th1, Th17 and Treg cells;Degree of cirrhosis;liver function test;Plasma fumarate concentration;Native liver survival at 6, 12,18, and 24 months;event-free survival at 6, 12, 18, and 24 months;	—

Countries

China

Contacts

Public ContactSong Sun

Children's Hospital of Fudan University

sun_song@fudan.edu.cn+86 15000773250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026