A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
Stopped early · Phase 2
Conditions studied: Hepatitis B, Chronic
In brief
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).
Key facts
- Study ID
- NCT05005507
- Run by
- Janssen Research & Development, LLC
- People needed
- 1
- Starts
- 2021-11-03
- Expected to finish
- 2021-12-29
- Last updated by the study team
- 2024-03-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive
- Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values < 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart
- Hepatitis B surface antigen (HBsAg) greater than (>) 5 IU/mL at screening
- Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) within 6 months prior to screening
You may not qualify if…
- History or signs of cirrhosis or portal hypertension
- Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection
- Liver disease of non-HBV etiology
- Clinically relevant alcohol or drug abuse within 12 months of screening
- Participants who meet any of the additional exclusion criteria for pegylated interferon alpha-2a (PegIFN- α2a) as described in local prescribing information (example, refer to Pegasys SmPC or Pegasys USPI) per the investigator's discretion. Key exclusion criteria for PegIFN- α2a include: a) Participants with signs or symptoms compatible with autoimmune disorders. b) Participants with bone marrow suppression. c) Participants with hypoglycaemia, hyperglycaemia, and/or diabetes mellitus, who cannot be effectively controlled by medication. d) Participants with pre-existing ophthalmologic disorders. e) Participants with one or more of the following laboratory abnormalities: i) Absolute neutrophil count less than (<)1,500 cells/mm3 (<1,000 cells/mm³ for black or African American participants). ii) Serum creatinine >1.5x ULN. iii) Inadequately controlled thyroid function (thyroid stimulating hormone [TSH] and thyroxine [T4]). f) Participants with a history of a severe psychiatric disorder including severe depression, suicidal ideation and attempted suicide, or a current depression or other psychiatric disorder that is not adequately controlled on a stable medication regimen
Where it is running
- I.D. Care, Inc. — Hillsborough, New Jersey, United States
- Vancouver ID Research and Care Centre Society — Vancouver, British Columbia, Canada
- GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada
- Kagawa Prefectural Central Hospital — Takamatsu, Japan
- PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p. — Gdansk, Poland
- ID Clinic — Mysłowice, Poland
- EMC Instytut Medyczny SA — Wroclaw, Poland
- Hosp. Univ. Vall D Hebron — Barcelona, Spain
- Hosp. Univ. Infanta Leonor — Madrid, Spain
- Hosp. Univ. Marques de Valdecilla — Santander, Spain
- Hosp. Alvaro Cunqueiro — Vigo, Spain
- National Cheng Kung University Hospital — Tainan, Taiwan
Full record on ClinicalTrials.gov
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