A Phase 4 interventional study of Egaten (Triclabendazole) 250 mg tablets in Fascioliasis, sponsored by Novartis Pharmaceuticals. Completed at 10 sites in 5 countries. Open to participants aged 6 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment
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).
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.
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 6, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Written must be obtained before any study protocol specific assessment is performed.
Exclusion Criteria:
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 :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food.
Drug: Egaten (Triclabendazole) 250 mg tablets
Egaten 250 mg scored tablets for oral use.
Also known as: Triclabendazole
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.
Time frame: Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 10, Day 30, Day 60 and Day 90
Participants took part in 10 investigative sites in 5 countries.
| Milestone | Triclabendazole |
|---|---|
| Started | 301 |
| Completed | 296 |
| Not completed | 5 |
| Withdrew: Subject decision | 2 |
| Withdrew: Lost to follow-up | 3 |
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
| Participants | Triclabendazole |
|---|---|
| Adverse Events | 139 |
| Serious Adverse Events | 7 |
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.
| percentage of participants | Triclabendazole |
|---|---|
| Acute fascioliasis | 95.7 (92.2 to 97.9) |
| Chronic fascioliasis | 75.0 (57.8 to 87.9) |
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.
| percentage of participants | Triclabendazole |
|---|---|
| Day 30 | 78.5 (72.8 to 83.5) |
| Day 60 | 83.5 (78.2 to 87.9) |
| Day 90 | 93.8 (90.0 to 96.5) |
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.
| percentage of participants | Triclabendazole |
|---|---|
| Day 30 | 12.8 (4.3 to 27.4) |
| Day 60 | 17.9 (7.5 to 33.5) |
| Day 90 | 17.9 (7.5 to 33.5) |
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.
| percentage of participants | Triclabendazole |
|---|---|
| Day 10 | 80.8 (60.6 to 93.4) |
| Day 30 | 84.6 (65.1 to 95.6) |
| Day 60 | 84.6 (65.1 to 95.6) |
| Day 90 | 84.6 (65.1 to 95.6) |
Collected over Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triclabendazole | 0/301 (0%) | 7/301 (2.3%) | 84/301 (27.9%) |
| Event | Triclabendazole |
|---|---|
| Liver abscessInfections and infestations | 2/301 |
| Adrenal insufficiencyEndocrine disorders | 1/301 |
| GastritisGastrointestinal disorders | 1/301 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/301 |
| CholecystitisHepatobiliary disorders | 1/301 |
| Gastrointestinal infectionInfections and infestations | 1/301 |
| PneumoniaInfections and infestations | 1/301 |
| SepsisInfections and infestations | 1/301 |
| Spinal column injuryInjury, poisoning and procedural complications | 1/301 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 1/301 |
| Event | Triclabendazole |
|---|---|
| Abdominal pain upperGastrointestinal disorders | 34/301 |
| UrticariaSkin and subcutaneous tissue disorders | 34/301 |
| Alanine aminotransferase increasedInvestigations | 28/301 |
| Aspartate aminotransferase increasedInvestigations | 21/301 |
| Gamma-glutamyltransferase increasedInvestigations | 16/301 |
| Age, Continuous(years) | Triclabendazole |
|---|---|
| Mean | 37.3 ± 14.81 |
| Sex: Female, Male(Participants) | Triclabendazole |
|---|---|
| Female | 185 |
| Male | 116 |
| Race/Ethnicity, Customized(Participants) | Triclabendazole |
|---|---|
| White | 27 |
| Asian | 260 |
| American Indian or Alaska Native | 14 |
| Types of Fascioliasis(Participants) | Triclabendazole |
|---|---|
| Acute fascioliasis participants | 246 |
| Chronic fascioliasis participants | 39 |
| Undetermined participants | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Ran from Feb 2022 to primary completion in Mar 2026, 49 months.
Results were first posted in Oct 2026, 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fascioliasis