Clinical Trial Results:
A Phase IV, multi-center, open-label study to determine the safety, tolerability and clinical outcomes following oral administration of EGATEN™ (Triclabendazole) in patients (6 years of age or older) with fascioliasis.
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Summary
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EudraCT number |
2020-004200-33 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
27 Mar 2026
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Sep 2026
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First version publication date |
27 Sep 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CEGA230B2404
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04230148 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
Lichtstrasse 35, Basel, Switzerland, 4056
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Mar 2026
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Mar 2026
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate safety and tolerability of EGATEN administered as two 10 mg/kg doses given approximately 12 hours apart in patients with fascioliasis.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Feb 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Colombia: 1
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Country: Number of subjects enrolled |
Egypt: 10
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Country: Number of subjects enrolled |
Peru: 13
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Country: Number of subjects enrolled |
Türkiye: 17
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Country: Number of subjects enrolled |
Viet Nam: 260
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Worldwide total number of subjects |
301
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
10
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Adolescents (12-17 years) |
14
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Adults (18-64 years) |
265
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants took part in 10 investigative sites in 5 countries. | ||||||||||||
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Pre-assignment
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Screening details |
The study consisted of a screening up to 3 days to assess eligibility. | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Triclabendazole | ||||||||||||
Arm description |
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triclabendazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food.
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Baseline characteristics reporting groups
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Reporting group title |
Triclabendazole
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Reporting group description |
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Triclabendazole
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Reporting group description |
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food. | ||
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End point title |
Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) [1] | ||||||||||
End point description |
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
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End point type |
Primary
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End point timeframe |
Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analyses are not applicable for this endpoint. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Percentage of acute and chronic fascioliasis participants who achieved Clinical Response | ||||||||||||
End point description |
Clinical Response at Day 10 was defined as improvement or resolution of baseline signs and symptoms.
95% confidence interval (CI) is calculated based on Clopper-Pearson method.
The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 10
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of acute fascioliasis participants who achieved Clinical Cure | ||||||||||||||
End point description |
A participant was considered to achieve clinical cure if all of the following criteria were met.
• Resolution of all sign and symptoms present at baseline
• Improvement in ultrasound findings:
Abdomen – for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)
• Improvement in the lab parameter from baseline:
Eosinophil count: ≥ 50% reduction from baseline value or reaching normal range if baseline value was above normal range
95% confidence interval (CI) is calculated based on Clopper-Pearson method.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 30, Day 60 and Day 90
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of chronic fascioliasis participants who achieved Clinical Cure | ||||||||||||||
End point description |
A participant was considered to achieve clinical cure if all of the following criteria were met.
• Resolution of all sign and symptoms present at baseline
• Improvement in ultrasound findings: Abdomen – for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)
• Improvement in the lab parameter from baseline:
Eosinophil count: ≥50% reduction from baseline or reaching normal range if baseline value was above normal range
Hemoglobin: ≥1 g/dL increase from baseline value or reaching normal range if baseline value was below normal range
Liver function test: ≥1 grade improvement from baseline or reaching normal range for each test if baseline value was above normal range
Erythrocyte sedimentation rate: ≥ 50% reduction from baseline or reaching normal range if baseline value was above normal range
95% CI is calculated based on Clopper-Pearson method.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 30, Day 60 and Day 90
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of chronic fascioliasis participants who achieved parasitological cure | ||||||||||||||||
End point description |
The parasitological cure rate in chronic fascioliasis participants was measured by the proportion of participants with absence of fasciola eggs confirmed by stool examination. In case of missing assessments at post baseline visits, parasitological cure is imputed as cured if two consecutive prior visits are negative, else parasitological cure is imputed as not cured. 95% confidence interval (CI) is calculated based on Clopper-Pearson method.
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End point type |
Secondary
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End point timeframe |
At Day 10, Day 30, Day 60 and Day 90
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
29.0
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Reporting groups
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Reporting group title |
EGATEN 10 mg BID
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Reporting group description |
EGATEN 10 mg BID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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10 May 2021 |
The primary purpose of this amendment was to incorporate safety ECG monitoring for a subset of patients enrolling into the study who may be at increased risk of QT prolongation. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
