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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04225923
Other study ID # NPC-21-2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 1, 2020
Est. completion date February 8, 2023

Study information

Verified date February 2023
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.


Description:

This is a Phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney transplant recipients at high risk of CMV infection in the United States and Japan. Approximately 108 eligible patients will be randomized prior to first study drug administration to receive low-dose NPC 21, high-dose NPC-21, or placebo. Randomization will be stratified by region (United States or Japan)


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NPC-21 Low dose
NPC-21 will be administered via an approximately 60-minute intravenous infusion
NPC-21 High dose
NPC-21 will be administered via an approximately 60-minute intravenous infusion
NPC-21 Placebo
Placebo will be administered via an approximately 60-minute intravenous infusion

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Sponsors (1)

Lead Sponsor Collaborator
Nobelpharma

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of CMV disease or CMV viremia Percentage of patients with adjudicated CMV disease or CMV viremia through 16 weeks post-transplant 16 weeks
Secondary Incidence of CMV disease or CMV viremia Percentage of patients with adjudicated CMV disease or CMV viremia. 28 weeks
Secondary Incidence of CMV disease Percentage of patients with adjudicated CMV disease 28 weeks
Secondary Incidence of CMV viremia Percentage of patients with adjudicated CMV viremia. 28 weeks
Secondary Time to detectable CMV disease or CMV viremia 28 weeks
Secondary Time to detectable CMV disease 28 weeks
Secondary Time to detectable CMV viremia 28 weeks
Secondary Amount of CMV DNA 28 weeks
Secondary Incidence and duration of anti-CMV therapy during the Rescue Phase 28 weeks
Secondary Changes in EQ-5D-5L score from Baseline 28 weeks
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