18 and older, any sex, with HCMV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Require Preemptive HCMV TherapyPrimary· 98 days
Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is \>= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is \< 1000 copies/mL, but HCMV disease was reported
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
24
Cohort 2: CSJ148
23
Cohort 2: Placebo
9
Number of Participants With Adverse Events as a Measure of Safety and TolerabilityPrimary· 98 days
Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.
At least one treatment-emergent AE
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
65
Cohort 2: Placebo
21
At least one drug-related AE
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
0
Cohort 2: Placebo
2
At least one SAE
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
46
Cohort 2: Placebo
15
At least one drug-related SAE
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
0
Cohort 2: Placebo
1
Deaths
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
12
Cohort 2: Placebo
0
At least 1 treatment-emergent AE grade 3 or higher
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
58
Cohort 2: Placebo
17
Total deaths:those reported after study completion
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
19
Cohort 2: Placebo
3
Discontinued study treatment due to any AE
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1
Cohort 2: Placebo
1
Time to Start of Preemptive HCMV Therapy Cohort 2Secondary· 98 days
The time to start preemptive therapy is defined as the number of days between initial dose of study drug and the earlier of (1) the start of preemptive therapy, and (2) the development of HCMV disease or death due to HCMV disease, or (3) censored at the EoT visit if no therapy required for Cohort 2
Group
Value
95% CI
Cohort 2: CSJ148
62.03
± 12.145
Cohort 2: Placebo
49.54
± 13.470
Number of Times That Preemptive HCMV Therapy is Required -Cohort 2Secondary· 98 days
Among those who required preemptive therapy, the number of times preemptive therapy was required. (Cohort 2)
Group
Value
95% CI
Cohort 2: CSJ148
2.070
1.369 – 3.130
Cohort 2: Placebo
2.540
1.342 – 4.806
Proportion of Participants Developing HCMV DiseaseSecondary· 98 days
Proportion of participants developing HCMV disease
Group
Value
95% CI
Cohort 2: CSJ148
0.119
0.048 – 0.234
Cohort 2: Placebo
0
0 – 0.162
Area Under the Serum Concentration-time Curve During the Dosing Interval (AUCtau) for CSJ148 OnlySecondary· Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose
PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The AUCtau was calculated using a linear trapezoidal method
Day 1
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
7310
± 2310
Day 29
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
9890
± 3470
Day 57
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
11400
± 4020
Day 85
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
12900
± 4380
Maximum Serum Concentration During the Dosing Interval (Cmax) for CSJ148 OnlySecondary· Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose
Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration \[ug / mL\] for CSJ148 only
Day 1
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1040
± 356
Day 29
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1100
± 282
Day 57
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1180
± 316
Day 85
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1230
± 458
Trough Serum Concentration (Ctrough) for CSJ148 OnlySecondary· Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose
Ctrough is The observed plasma (or serum or blood) concentration at the end of a drug administration dosing interval \[ug / mL\]
Day 1
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
104
± 59.7
Day 29
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
167
± 85.5
Day 57
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
214
± 152
Day 85
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
223
± 104
Accumulation Ratio(Racc) for CSJ148 Only at Day 85Secondary· Day 1 and Day 85
Accumulation ratio(Racc) is Racc: Accumulation ratio, calculated by AUCtau (Day 85) divided by AUCtau (for the 1st dose at Day 1).
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
1.83
± 0.531
Lambda_z for CSJ148 Only at Day 85Secondary· Day 85
Lambda\_z is the terminal elimination rate constant \[1/day\] at Day 85
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
0.0409
± 0.0175
Half-life (T1/2) for CSJ148 Only at Day 85Secondary· Day 85
T1/2 is the terminal elimination half-life \[time\]
Group
Value
95% CI
Total CSJ148 (Cohort 1 & Cohort 2)
19.7
± 7.18
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit 183 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 15/21 (71%)
Deaths: —
Total CSJ148
Serious: 46/65 (71%)
Deaths: —
Serious adverse events (124 terms)
Reaction
System
Placebo
Total CSJ148
Acute graft versus host disease
Immune system disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Non-cardiac chest pain
General disorders
—
—
Septic shock
Infections and infestations
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Atrial flutter
Cardiac disorders
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Cytomegalovirus colitis
Infections and infestations
—
—
Cytomegalovirus infection
Infections and infestations
—
—
Cytomegalovirus viraemia
Infections and infestations
—
—
Epstein-Barr virus infection
Infections and infestations
—
—
Herpes zoster
Infections and infestations
—
—
Staphylococcal sepsis
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Alanine aminotransferase increased
Investigations
—
—
Other adverse events (119 terms — click to expand)
NCT03369912 — A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
· Phase 2
· withdrawn
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 5 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02268526.