Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-24 @ 12:17 AM
Study NCT ID:
NCT02826018
Status:
TERMINATED
Last Update Posted:
2018-09-24
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06-24'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects experiencing adverse events', 'timeFrame': 'Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176'}], 'secondaryOutcomes': [{'measure': 'Profile of Pharmacokinetics (PK) of ALN-HBV', 'timeFrame': 'Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Profile of Pharmacokinetics (PK) of ALN-HBV', 'timeFrame': 'Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85', 'description': 'Elimination half-life (t1/2)'}, {'measure': 'Profile of Pharmacokinetics (PK) of ALN-HBV', 'timeFrame': 'Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels', 'timeFrame': 'Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176', 'description': 'Change in HBsAg levels from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['RNAi therapeutic', 'Hepatitis B', 'Chronic Hepatitis B', 'Hepatitis B, Chronic', 'Hepatitis B Infection', 'HBV'], 'conditions': ['Hepatitis B', 'Chronic Hepatitis B', 'Hepatitis B, Chronic', 'Hepatitis B Infection', 'HBV']}, 'referencesModule': {'references': [{'pmid': '37290591', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.', 'detailedDescription': 'The study has 3 parts. Part A is a single ascending dose (SAD) study in healthy volunteers. Part B is a single ascending dose study (SAD) in patients with HBV infection. Part C is a multiple ascending dose study (MAD) in patients with HBV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects:\n\n* 18 to 65 years inclusive\n* 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\n* Agrees not to donate blood during the duration of the study\n* Willing to comply with the study requirements and to provide written informed consent\n\nAdditional inclusion criteria for patients with HBV infection:\n\n* Body mass index (BMI) ≥18.0 kg/m2\n* Must be on a stable regimen of entecavir or tenofovir\n\nExclusion Criteria:\n\nAll subjects:\n\n* 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\n* Subjects with a history of serious mental illness\n* 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\n* Known hypersensitivity or contraindication to any medication or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)\n\nAdditional exclusion criteria for healthy volunteers:\n\n* Evidence of liver disease'}, 'identificationModule': {'nctId': 'NCT02826018', 'briefTitle': 'A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Phase 1/2, Randomized, Single-Blind, Placebo-Controlled, Single-Ascending and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Antiviral Efficacy Study of Subcutaneously Administered ALN-HBV in Healthy Adult Subjects and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection', 'orgStudyIdInfo': {'id': 'ALN-HBV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ALN-HBV', 'interventionNames': ['Drug: ALN-HBV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile Normal Saline (0.9% NaCl)', 'interventionNames': ['Drug: Sterile Normal Saline (0.9% NaCl)']}], 'interventions': [{'name': 'ALN-HBV', 'type': 'DRUG', 'description': 'Ascending doses of ALN-HBV by subcutaneous (sc) injection', 'armGroupLabels': ['ALN-HBV']}, {'name': 'Sterile Normal Saline (0.9% NaCl)', 'type': 'DRUG', 'description': 'Calculated volume to match active comparator', 'armGroupLabels': ['Sterile Normal Saline (0.9% NaCl)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Stephen Huang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alnylam Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}