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Virus Therapy
Letermovir for Congenital CMV Infection
Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic congenital CMV disease*
Weight at study enrollment 2.6 kg to < 8.0 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 14
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a drug called letermovir in newborns with symptomatic congenital Cytomegalovirus (CMV) disease. The newborns will be divided into two groups
Who is the study for?
This trial is for infants with symptomatic congenital CMV disease who are planned to be treated with oral valganciclovir for 6 months. Eligible infants must have confirmed CMV, weigh between 2.6 kg and <8.0 kg, be at least 32 weeks gestational age at birth, and show symptoms like thrombocytopenia or CNS involvement.
What is being tested?
The study tests the safety of oral Letermovir in newborns with symptomatic congenital Cytomegalovirus (CMV). It's a Phase 1 trial where subjects receive one dose followed by a pharmacokinetics profile assessment over 24 hours to determine appropriate dosing for a subsequent 14-day treatment course.
What are the potential side effects?
While specific side effects are not listed here, the trial includes monitoring blood samples on several days post-treatment initiation for safety chemistry and hematology labs as well as adverse events assessments during visits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms of a congenital CMV infection.
Select...
My weight is between 2.6 kg and 8 kg.
Select...
My baby was born at or after 32 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma letermovir area under the curve (AUC24) concentrations
Secondary study objectives
Frequency of grade 3 adverse events (AEs)
Frequency of grade 4 adverse events (AEs)
Plasma letermovir half-life (T1/2)
Side effects data
From 2016 Phase 3 trial • 570 Patients • NCT0213777239%
Graft versus host disease
29%
Diarrhoea
28%
Nausea
24%
Rash
23%
Pyrexia
21%
Vomiting
17%
Cough
16%
Oedema peripheral
16%
Headache
15%
Cytomegalovirus infection
15%
Fatigue
13%
Abdominal pain
12%
Mucosal inflammation
12%
Decreased appetite
10%
Blood creatinine increased
10%
Dyspnoea
9%
Hypertension
9%
Acute kidney injury
9%
Oropharyngeal pain
9%
Insomnia
9%
Erythema
8%
Febrile neutropenia
8%
Hyperkalaemia
8%
Asthenia
8%
Hyperglycaemia
8%
Constipation
8%
Arthralgia
8%
Dizziness
8%
Tremor
8%
Dry skin
8%
Pruritus
7%
Alanine aminotransferase increased
7%
Epistaxis
7%
Thrombocytopenia
6%
Dyspepsia
6%
Stomatitis
6%
Bacteraemia
6%
Aspartate aminotransferase increased
6%
Acute myeloid leukaemia recurrent
6%
Anaemia
6%
Dry eye
6%
Abdominal pain upper
6%
Dry mouth
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Back pain
6%
Myalgia
6%
Anxiety
5%
Nasopharyngitis
5%
Dysuria
5%
Neutropenia
5%
Chest pain
5%
Pain in extremity
5%
Dysgeusia
4%
Hypotension
4%
Pneumonia
4%
Rhinorrhoea
3%
Viraemia
3%
Muscle spasms
2%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Hepatic function abnormal
1%
Sinusitis
1%
Viral haemorrhagic cystitis
1%
Urinary tract infection
1%
Venoocclusive liver disease
1%
Multiple organ dysfunction syndrome
1%
Pneumonia bacterial
1%
Squamous cell carcinoma
1%
Plasma cell myeloma recurrent
1%
Staphylococcal bacteraemia
1%
Pneumothorax
1%
Gastroenteritis
1%
Gastrointestinal haemorrhage
1%
Herpes zoster
1%
Pleural effusion
1%
Pancytopenia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Transplant failure
1%
Myelodysplastic syndrome
1%
Epstein-Barr virus infection
1%
Gastroenteritis viral
1%
Rhinovirus infection
1%
Septic shock
1%
Neurotoxicity
1%
Acute lymphocytic leukaemia
1%
Mantle cell lymphoma
1%
Sciatica
1%
Syncope
1%
Cystitis haemorrhagic
1%
Acute respiratory distress syndrome
1%
Venoocclusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Letermovir
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Neonates (\</= 28 days) with symptomatic congenital Cytomegalovirus (CMV) disease will initiate a 14-day course of once-daily oral letermovir, using weight dose banding. All subjects also will receive valganciclovir as standard of care. A dose escalation safety evaluation will occur to ensure the safety data support subjects proceeding. If the median of observed letermovir exposures of subjects in Group 1 is below 34,400 ngxhr/mL (or above 100,000 ngxhr/mL), then the subjects enrolled in Group 2 will receive once-daily oral letermovir at a dose that has been adjusted upward (or downward) in 2.5 mg increments. N=8
Group II: Group 1Experimental Treatment1 Intervention
Neonates (\</= 21 days) with symptomatic congenital Cytomegalovirus (CMV) disease will receive one dose of oral letermovir, using weight dose banding. All subjects also will receive valganciclovir as standard of care. A dose safety evaluation will occur to ensure the safety data support subjects proceeding. If the observed letermovir exposure is \</= 100,000 ngxhr/mL, the subject will initiate a 14-day course of once-daily oral letermovir at the same dose as utilized on the Dose Finding Day. If the observed letermovir exposure of the subject is \> 100,000 ngxhr/mL, the once-daily oral letermovir dose that will be used will be adjusted down in 2.5 mg increments from the dose utilized on the Dose Finding Day. N = 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1530
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,335 Previous Clinical Trials
5,382,792 Total Patients Enrolled
1 Trials studying Cytomegalovirus Congenital Infection
7 Patients Enrolled for Cytomegalovirus Congenital Infection