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

NCT04390113 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-05-14

Study results available
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Summary

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

Conditions

  • BK Virus Infection
  • Hemorrhagic Cystitis

Interventions

BIOLOGICAL

Posoleucel (ALVR105)

Administered as 2-4 milliliter infusion, visually identical to placebo

BIOLOGICAL

Placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Sponsors & Collaborators

  • AlloVir

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2024-01-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390113 on ClinicalTrials.gov