Badanie bezpieczeństwa, tolerancji i wyników klinicznych preparatu Egaten u pacjentów z fascioliazą (w wieku 6 lat lub starszych).
Wieloośrodkowe, otwarte badanie fazy IV mające na celu określenie bezpieczeństwa, tolerancji i wyników klinicznych po podaniu doustnym EGATEN™ (triklabendazolu) pacjentom (w wieku 6 lat lub starszym) z fascioliazą.
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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
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Alexandria, Egipt, 21131
- Novartis Investigative Site
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Egypt
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Cairo, Egypt, Egipt, 11617
- Novartis Investigative Site
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Antioquia
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Medellín, Antioquia, Kolumbia, 050010
- Novartis Investigative Site
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Cusco, Peru, 08002
- Novartis Investigative Site
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Lima region
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San Martín de Porres, Lima region, Peru, 15102
- Novartis Investigative Site
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Sur, Turcja (Türkiye), 21280
- Novartis Investigative Site
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Van, Turcja (Türkiye), 65080
- Novartis Investigative Site
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Fatih
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Istanbul, Fatih, Turcja (Türkiye), 34093
- Novartis Investigative Site
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Sehitkamil
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Gaziantep, Sehitkamil, Turcja (Türkiye), 27310
- Novartis Investigative Site
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Binh Dinh
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Qui Nhon, Binh Dinh, Wietnam, 590000
- Novartis Investigative Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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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.
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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.
Exclusion Criteria:
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Subjects diagnosed with ectopic fascioliasis, extrahepatic involvement (e.g., lungs, spleen, pancreas, subcutaneous tissue, gastrointestinal organs, etc.).
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Subjects with known hypersensitivity to triclabendazole /other benzimidazole derivatives and/or any of the excipients in Egaten.
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Subjects taking any anthelmintic medications within two weeks or 5 half-lives, whichever is longer prior to enrolling into study.
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Inability or unwillingness to undergo study related procedures.
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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.
- Medical history of liver (other than fascioliasis), kidney or cardiac disease.
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Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.
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Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.
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Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin).
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Egaten
Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food. |
Egaten 250 mg scored tablets for oral use.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
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Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. |
Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Acute and Chronic Fascioliasis Participants Who Achieved Clinical Response
Ramy czasowe: Baseline, Day 10
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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. |
Baseline, Day 10
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Percentage of Acute Fascioliasis Participants Who Achieved Clinical Cure
Ramy czasowe: Baseline, Day 30, Day 60 and Day 90
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A participant was considered to achieve clinical cure if all of the following criteria were met.
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. |
Baseline, Day 30, Day 60 and Day 90
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Percentage of Chronic Fascioliasis Participants Who Achieved Clinical Cure
Ramy czasowe: Baseline, Day 30, Day 60 and Day 90
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A participant was considered to achieve clinical cure if all of the following criteria were met.
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. |
Baseline, Day 30, Day 60 and Day 90
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Percentage of Chronic Fascioliasis Participants Who Achieved Parasitological Cure
Ramy czasowe: At Day 10, Day 30, Day 60 and Day 90
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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. |
At Day 10, Day 30, Day 60 and Day 90
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CEGA230B2404
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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