FascioliasisPhase 4NCT04230148
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
A Phase 4 study testing Egaten (Triclabendazole) 250 mg tablets in people with Fascioliasis, run by Novartis Pharmaceuticals at 10 sites in 5 countries.
Trial summary
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age). Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Fascioliasis
- What is being tested?
- Egaten (Triclabendazole) 250 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 11 Feb 2022to 27 Mar 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any study protocol specific assessment is performed.
- Parental/legal guardian informed consent must be obtained and signed for pediatric subjects prior to any study related procedure.
- Subjects < 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines.
- If the subject is unable to read and write or otherwise incapable of signing an informed consent, then a witnessed consent according to local ethical standards is permitted.
- Subjects (Adult and pediatric subjects ≥ 6 years of age and above 12.5 kg of weight) at time of consenting must have been diagnosed with fascioliasis based on clinical signs, symptoms and laboratory evaluations as per local clinical practice.
Who cannot join
- Subjects diagnosed with ectopic fascioliasis, extrahepatic involvement (e.g., lungs, spleen, pancreas, subcutaneous tissue, gastrointestinal organs, etc.).
- Subjects with known hypersensitivity to triclabendazole /other benzimidazole derivatives and/or any of the excipients in Egaten.
- Subjects taking any anthelmintic medications within two weeks or 5 half-lives, whichever is longer prior to enrolling into study.
- Inability or unwillingness to undergo study related procedures.
- Subjects who in the judgment of the Clinical Investigator are unsuitable for the trial or who have to be excluded in order to be compliant with local fascioliasis management guidelines that may differ from the FDA approved label, including but not limited to :
- Subjects who are machine operators or drivers.
Show all 11Show fewer
- Medical history of liver (other than fascioliasis), kidney or cardiac disease.
- Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.
- Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.
- Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin).
- Subjects with medical history of QT prolongation or a history of symptoms compatible with a long QT interval or on medication which prolong the QT interval.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Turkey (Türkiye)4 sites
Novartis Investigative Site
Gaziantep, Sehitkamil, 27310
Novartis Investigative Site
Istanbul, Fatih, 34093
Novartis Investigative Site
Sur, 21280
Novartis Investigative Site
Van, 65080
Egypt2 sites
Novartis Investigative Site
Alexandria, 21131
Novartis Investigative Site
Cairo, Egypt, 11617
Peru2 sites
Novartis Investigative Site
Cusco, 08002
Novartis Investigative Site
San Martín de Porres, Lima region, 15102
About this study
Official title: 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.
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age).
Read the detailed description
This was an open-label, single-arm, multi-center multi-country, non-comparative study planned in adult and pediatric participants (≥ 6 years of age) with acute or chronic fascioliasis.
Screening/Baseline: Screening and baseline assessments were performed as per protocol.
Treatment phase: Enrolled participants were treated with two doses of 10 mg/kg triclabendazole given approximately 12 hours apart, with the first dose administered on Day 1 under site study team's supervision. The second dose was either taken at home (self-administered) or administered at the site.
Follow-up phase: Post-treatment at Day 3 and Day 6, the enrolled participants were followed for safety and tolerability. These visits were conducted by telephone, through home visits by qualified personnel, or through onsite visits, based on the investigator's discretion. During the post treatment study site visits at Day 10, Day 30, Day 60, and Day 90 (EOS visit), the enrolled participants were followed for safety, tolerability, and efficacy. On Day 15, Day 45, and Day 75, telephonic follow ups (primarily for safety) were conducted.
- Conditions
- Fascioliasis
- Being tested
- Egaten (Triclabendazole) 250 mg tablets
- Keywords
- Acute Fascioliasis, Chronic Fascioliasis, Clinical Cure, Parasitological Cure, Egaten, Triclabendazole, Post-Marketing commitment
- Medical subject headings
- Fascioliasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egaten (Triclabendazole) 250 mg tabletsDrug
Also called Triclabendazole
Egaten 250 mg scored tablets for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Egaten | Experimental | Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food. Receives: Drug: Egaten (Triclabendazole) 250 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Measured: Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
Secondary outcomes (4)
Percentage of Acute and Chronic Fascioliasis Participants Who Achieved Clinical Response
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.
Measured: Baseline, Day 10
Percentage of Acute Fascioliasis Participants Who Achieved Clinical Cure
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.
Measured: Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Clinical Cure
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.
Measured: Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Parasitological Cure
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.
Measured: At Day 10, Day 30, Day 60 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start11 Feb 2022
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FascioliasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230148
- Sponsor's protocol ID
- CEGA230B2404
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com