NCT05550519VisszavonvaKorai 1. fázis
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients With Low On-treatment HBsAg Level
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 25.
Megadott ok: Sponsor Decision after re-evaluation of strategy in the context of recruitment timelines projection
Rövid összefoglaló (regiszter, angolul)
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.
- Állapot (regiszter)
- Visszavonva
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2022. szept. 20.
- Kezdés
- 2022. okt. 31.
- Elsődleges befejezés
- 2025. aug. 25.
- Fő szponzor
- Janssen Pharmaceutica N.V., Belgium
- Betegségek
- Hepatitis B (krónikus)
- NCT-szám
- NCT05550519
- EudraCT-szám
- 2021-005588-39
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Korábbi kezelés
- History of or signs of cirrhosis or portal hypertension (absence of nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to [>=] 12 centimeters [cm]) or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 3 months prior to screening (based on documented evidence, if available) or at the time of screening. In case of suspicious findings on conventional ultrasound the participant may still be eligible if HCC or clinically relevant renal abnormalities have been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography [CT] or magnetic resonance imaging [MRI])
- Participants with clinically relevant drug or alcohol abuse within 12 months before screening
- Received an investigational intervention or used an invasive investigational medical device within 3 months before the planned enrollment or is currently enrolled in an investigational study
Egyéb
- Participant's refusal to accept blood transfusions
- Participants of Asian descent
Kiket keres a vizsgálat
- Medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening and during the pre-biopsy assessments. If the results of the serum chemistry panel including liver enzymes, blood coagulation, other specific tests, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study (in consultation with sponsor)
- Hepatitis B surface antigen (HBsAg) less than or equal to (<=) 500 International units per milliliters (IU/mL) (and greater than [>] 5 IU/mL) at screening
- Hepatitis B e antigen (HBeAg) less than (<) lower limit of quantification and hepatitis B e antibody (HBeAb) positive at screening
- Normal liver ultrasound (at screening or within 3 months before screening [documented evidence])
- Participants must have a body mass index between 18.0 and 35.0 Kilograms per meter square (kg/m\^2), extremes included
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