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Virus Therapy

NPC-21 Low dose for Cytomegalovirus

Phase 2
Waitlist Available
Research Sponsored by Nobelpharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks

Summary

This trial is testing NPC-21, a new drug, to see if it can prevent CMV infections in patients who have just received their first kidney transplant from donors with CMV. These patients are at high risk because they do not have immunity against the virus. NPC-21 aims to protect them by stopping the virus from infecting their bodies.

Eligible Conditions
  • Cytomegalovirus (CMV)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of CMV Disease or CMV Viremia
Secondary study objectives
Incidence of CMV Disease
Incidence of CMV Viremia
Time to Detectable CMV Disease
+2 more

Side effects data

From 2023 Phase 2 trial • 87 Patients • NCT04225923
64%
Cytomegalovirus viraemia
27%
Diarrhoea
27%
Urinary tract infection
18%
Fatigue
18%
Anxiety
18%
Constipation
18%
Hypomagnesaemia
18%
Leukopenia
18%
Tremor
9%
Atrioventricular block first degree
9%
Atrioventricular block
9%
Insomnia
9%
Scrotal injury
9%
Seasonal allergy
9%
Myalgia
9%
Peripheral swelling
9%
Osteodystrophy
9%
Neuropathy peripheral
9%
Pyrexia
9%
Back pain
9%
Nasal congestion
9%
Pruritus
9%
Hyperuricaemia
9%
Dizziness postural
9%
Hyperkalaemia
9%
Perinephric collection
9%
Nausea
9%
Polyomavirus viraemia
9%
Blood triglycerides increased
9%
Pyelonephritis
9%
Impaired healing
9%
Ear pain
9%
Stomatitis
9%
Amylase increased
9%
Lipase increased
9%
Hepatic enzyme increased
9%
Headache
9%
Depression
9%
Scrotal swelling
9%
Alopecia
9%
Clostridium difficile colitis
9%
Onycholysis
9%
Blood lactate dehydrogenase increased
9%
Oedema peripheral
9%
Ecchymosis
9%
Donor specific antibody present
9%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPC-21 Placebo
NPC-21 High Dose
NPC-21 Low Dose

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NPC-21 Low doseExperimental Treatment1 Intervention
NPC-21 (6mg/kg) will be administered
Group II: NPC-21 High doseExperimental Treatment1 Intervention
NPC-21 (12mg/kg) will be administered
Group III: NPC-21 PlaceboPlacebo Group1 Intervention
Placebo (normal saline) will be administered
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NPC-21 High dose
2020
Completed Phase 2
~90
NPC-21 Low dose
2020
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

NobelpharmaLead Sponsor
35 Previous Clinical Trials
2,110 Total Patients Enrolled
~16 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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