A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT02826018
Last Updated: 2018-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2016-06-24
2017-10-31
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
SINGLE
Study Groups
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ALN-HBV
ALN-HBV
Ascending doses of ALN-HBV by subcutaneous (sc) injection
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Interventions
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ALN-HBV
Ascending doses of ALN-HBV by subcutaneous (sc) injection
Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Eligibility Criteria
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Inclusion Criteria
* 18 to 65 years inclusive
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception
* Agrees not to donate blood during the duration of the study
* Willing to comply with the study requirements and to provide written informed consent
* Body mass index (BMI) ≥18.0 kg/m2
* Must be on a stable regimen of entecavir or tenofovir
Exclusion Criteria
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk
* Subjects with a history of serious mental illness
* Active infection with human immunodeficiency virus (HIV) infection, hepatitis A virus (HAV), or hepatitis C virus (HCV) infection and/or a history of delta virus hepatitis
* Known hypersensitivity or contraindication to any medication or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)
* Evidence of liver disease
18 Years
65 Years
ALL
Yes
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Huang, MD
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Adelaide, South Australia, Australia
Clinical Trial Site
Fitzroy, Victoria, Australia
Clinical Trial Site
Parkville, Victoria, Australia
Clinical Trial Site
Hong Kong, , Hong Kong
Clinical Trial Site
Auckland, , New Zealand
Clinical Trial Site
Singapore, , Singapore
Clinical Trial Site
Seoul, , South Korea
Clinical Trial Site
Seoul, , South Korea
Clinical Trial Site
London, , United Kingdom
Countries
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References
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Gane E, Lim YS, Kim JB, Jadhav V, Shen L, Bakardjiev AI, Huang SA, Cathcart AL, Lempp FA, Janas MM, Cloutier DJ, Kaittanis C, Sepp-Lorenzino L, Hinkle G, Taubel J, Haslett P, Milstein S, Anglero-Rodriguez YI, Hebner CM, Pang PS, Yuen MF. Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials. J Hepatol. 2023 Oct;79(4):924-932. doi: 10.1016/j.jhep.2023.05.023. Epub 2023 Jun 7.
Other Identifiers
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ALN-HBV-001
Identifier Type: -
Identifier Source: org_study_id
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