Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
NCT ID: NCT03365947
Last Updated: 2025-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
114 participants
INTERVENTIONAL
2018-03-27
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ARO-HBV 35 mg
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
ARO-HBV
sc injection
ARO-HBV 100 mg
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
ARO-HBV
sc injection
ARO-HBV 200 mg
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
ARO-HBV
sc injection
ARO-HBV 300 mg
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
ARO-HBV
sc injection
ARO-HBV 400 mg
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
ARO-HBV
sc injection
Placebo
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
Sterile Normal Saline (0.9% NaCl)
sc injection
ARO-HBV 25 mg, Q28D
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 50 mg Q28D
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 100 mg Q28D
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 200 mg Q28D
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 300 mg Q28D
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 400 mg Q28D
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 100 mg Q14D
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 100 mg Q7D
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve
ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 300 mg, Q28D, HBeAg+/ NUC
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 200 mg, Q7D
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 300 mg, Q7D
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
ARO-HBV
sc injection
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
ARO-HBV
sc injection
JNJ-56136379
oral tablets
Interventions
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ARO-HBV
sc injection
Sterile Normal Saline (0.9% NaCl)
sc injection
JNJ-56136379
oral tablets
Eligibility Criteria
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Inclusion Criteria
* Willing to provide written informed consent and comply with study requirements
* Diagnosis of chronic HBV infection
* Hepatitis B surface antigen (HbsAg) at screening \> or = 50 IU/mL
* Liver Elastography score \< or = 10.5
Exclusion Criteria
* Abnormal for any clinical safety laboratory result considered clinically significant
* Regular use of alcohol within 1 month prior to screening
* Recent use of illicit drugs
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
18 Years
65 Years
ALL
Yes
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Site 5
Camperdown, New South Wales, Australia
Research Site 4
Clayton, Victoria, Australia
Research Site 3
Melbourne, Victoria, Australia
Research Site 6
Nedlands, Western Australia, Australia
Research Site 7
Hong Kong, , Hong Kong
Research Site 1
Grafton, Auckland, New Zealand
Research Site 2
Papatoetoe, Auckland, New Zealand
Countries
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References
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Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20.
Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AROHBV1001
Identifier Type: -
Identifier Source: org_study_id
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