NCT04376528 is a Phase 4 clinical trial of Cyclosporin A in Hepatitis, Autoimmune, sponsored by West China Hospital.

Who is sponsoring NCT04376528?

NCT04376528 is sponsored by West China Hospital.

What drugs are being tested in NCT04376528?

Interventions in NCT04376528: Cyclosporin A, Mycophenolate Mofetil.

What condition does NCT04376528 study?

NCT04376528 studies Hepatitis, Autoimmune, Primary Biliary Cholangitis, Immunosuppression.

Is NCT04376528 still recruiting?

NCT04376528 is currently status unknown. Last updated 22 June 2021.

Last reviewed 2021-06-22 · How we verify

NCT04376528

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

Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

Status unknown Phase 4 Last updated 22 June 2021

What this trial tests

Phase 4 trial testing Cyclosporin A in Hepatitis, Autoimmune in 89 participants. Status unknown.

Timeline

16 June 2021

Primary endpoint
30 December 2021

30 December 2021

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	89
Start date	16 June 2021
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across China

Drugs / interventions tested

Cyclosporin A — full drug profile →
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →

Conditions studied

Hepatitis, Autoimmune — all drugs for Hepatitis, Autoimmune →
Primary Biliary Cholangitis — all drugs for Primary Biliary Cholangitis →
Immunosuppression — all drugs for Immunosuppression →

Sponsor

West China Hospital

Who can join

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

Sponsor's own description

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A

Publications & conference data

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

Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial.
Snijders RJALM, Stoelinga AEC, Gevers TJG, Pape S, et al · · 2022 · cited 7× · PMID 36514163 · DOI 10.1186/s13063-022-06890-w
Biliary fibrosis is an important but neglected pathological feature in hepatobiliary disorders: from molecular mechanisms to clinical implications.
Zhao J, Yue P, Mi N, Li M, et al · · 2024 · cited 5× · PMID 39135601 · DOI 10.1515/mr-2024-0029

Verify or expand the search:

Other trials of Cyclosporin A

Trials testing the same drug.

NCT06525948 — Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA · Phase 4 · not yet recruiting
NCT06246786 — Breast/Cyclosporin A/TNBC (Triple Negative Breast Cancer) · EARLY_PHASE1 · withdrawn
NCT04945096 — Outcomes of Patients After Allo-HSCT With Decitabine and NAC · Phase 3 · unknown
NCT04537689 — Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis · Phase 4 · recruiting
NCT04688021 — A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT. · Phase 2 · unknown

Other recruiting trials for Hepatitis, Autoimmune

Currently open trials in the same condition.

NCT02997878 — Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH · Phase 1, PHASE2 · active not recruiting
NCT03146884 — Swiss Autoimmune Hepatitis Cohort Study · 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 NCT04376528 (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: 22 June 2021

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/NCT04376528.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing