Study to Evaluate Viralym-M (ALVR105) for the Treatment of

Status Terminated

Clinical Trial Summary

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

Clinical Trial Description

The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04390113
Study type	Interventional
Source	AlloVir
Contact
Status	Terminated
Phase	Phase 3
Start date	March 18, 2021
Completion date	January 30, 2024

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See also
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