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NCT05912946

Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis

Status unknown Phase 2, PHASE3 Last updated 15 September 2023
What this trial tests

Phase 2, PHASE3 trial testing Interferon in Interstitial Cystitis in 129 participants. Status unknown.

Timeline
15 October 2023
Primary endpoint
15 October 2024
15 October 2024

Quick facts

Lead sponsorWest China Hospital
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment129
Start date15 October 2023
Primary completion15 October 2024
Estimated completion15 October 2024

Drugs / interventions tested

Conditions studied

Sponsor

West China Hospital

Who can join

Eligibility, female only, with Interstitial Cystitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Interstitial cystitis/bladder pain syndrome (IC/BPS) is one of the most intractable diseases of Urogynecology. The main clinical manifestations of interstitial cystitis/bladder pain are frequent urination and severe overflowing bladder pain. Due to the unclear pathological mechanism and the diversity of clinical manifestations and pathological features of the disease, the diagnosis is mainly to exclude suspicious diseases. At present, IC/BPS treatment mainly includes oral administration of mast cell stabilizing drugs such as sodium pentosan sulfate and anticholinergic drugs, or bladder instillation of dimethyl sulfone, hyaluronic acid and other drugs directly acting on the bladder mucosa, or surgical treatment such as sacrospinal radiculotomy and peripheral denervation of the bladder, but all can only relieve clinical symptoms and improve quality of life, and can not be targeted etiological treatment according to the pathological mechanism. Research showed JC polyomavirus (JCPyV) virus may be the original pathogen causing the development of IC/BPS. Interferon, as a broad-body antiviral agent, plays a critical role in triggering innate and adaptive immune responses against viral replication and infection. It can inhibit the replication and transcription of JCPyV through a variety of pathways. Interferon may be a potential specific drug for IC/BPS. Therefore, this study aims to evaluate the efficacy and safety of interferon bladder perfusion for IC/BPS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Intravesical Interferon Therapy vs Hyaluronic Acid for Pain Among Female Individuals With Interstitial Cystitis: A Randomized Clinical Trial.
    Shen SH, Peng L, Zeng X, Zhang J, et al · · 2024 · cited 11× · PMID 38587846 · DOI 10.1001/jamanetworkopen.2024.4880

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Other trials of Interferon

Trials testing the same drug.

Other recruiting trials for Interstitial Cystitis

Currently open trials in the same condition.

Other West China Hospital trials

Trials by the same sponsor.

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