Who is sponsoring NCT03345589?

NCT03345589 is sponsored by West China Hospital.

What drugs are being tested in NCT03345589?

Interventions in NCT03345589: 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic.

What condition does NCT03345589 study?

NCT03345589 studies Primary Biliary Cholangitis.

Is NCT03345589 still recruiting?

NCT03345589 is currently status unknown. Last updated 3 May 2018.

Last reviewed 2018-05-03 · How we verify

NCT03345589

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

Status unknown Phase 4 Last updated 3 May 2018

What this trial tests

Phase 4 trial testing 18-22mg/kg/d Ursodeoxycholic in Primary Biliary Cholangitis in 40 participants. Status unknown.

Timeline

30 January 2018

Primary endpoint
1 December 2018

1 January 2019

Quick facts

Lead sponsor	West China Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	30 January 2018
Primary completion	1 December 2018
Estimated completion	1 January 2019
Sites	1 location across China

Drugs / interventions tested

18-22mg/kg/d Ursodeoxycholic — full drug profile →
13-15mg/kg/d Ursodeoxycholic — full drug profile →

Conditions studied

Primary Biliary Cholangitis — all drugs for Primary Biliary Cholangitis →

Sponsor

West China Hospital

Who can join

Adults 18 to 70, any sex, with Primary Biliary Cholangitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antihepatic Fibrosis Drugs in Clinical Trials.
Guo YC, Lu LG. · · 2020 · cited 24× · PMID 33083254 · DOI 10.14218/jcth.2020.00023
Understanding fatigue in primary biliary cholangitis: From pathophysiology to treatment perspectives.
Lynch EN, Campani C, Innocenti T, Dragoni G, et al · · 2022 · cited 21× · PMID 35978669 · DOI 10.4254/wjh.v14.i6.1111
Emerging therapies for PBC.
Chascsa DMH, Lindor KD. · · 2020 · cited 16× · PMID 31970467 · DOI 10.1007/s00535-020-01664-0
Ursodeoxycholic Acid at 18-22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis.
Xiang X, Yang X, Shen M, Huang C, et al · · 2021 · cited 7× · PMID 33542908 · DOI 10.1155/2021/6691425
Update on Emerging Treatment Options for Primary Biliary Cholangitis.
Aguilar MT, Chascsa DM. · · 2020 · cited 6× · PMID 32547264 · DOI 10.2147/hmer.s205431
Novel Therapies for Managing Cholestasis.
Santiago P, Levy C. · · 2020 · cited 3× · PMID 32257119 · DOI 10.1002/cld.886
Pretransplant Evaluation and Liver Transplantation Outcome in PBC Patients.
Mijic M, Saric I, Delija B, Lalovac M, et al · · 2022 · cited 2× · PMID 35910038 · DOI 10.1155/2022/7831165
From chemical composition to clinical application: the value of bile-based traditional Chinese medicines in the treatment of liver diseases.
Liang X, Liang Y, Liu S, Yu L, et al · · 2026 · PMID 42110532 · DOI 10.3389/fphar.2026.1789551

Verify or expand the search:

Other recruiting trials for Primary Biliary Cholangitis

Currently open trials in the same condition.

NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
NCT07282353 — A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA · Phase 3 · recruiting
NCT06730061 — A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) · Phase 3 · active not recruiting
NCT06447168 — A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholang · recruiting
NCT06427395 — Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis · Phase 3 · recruiting

Other West China Hospital trials

Trials by the same sponsor.

NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
NCT07583914 — Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
NCT07472933 — Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03345589 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by West China Hospital
Last refreshed: 3 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03345589.

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