A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

NCT02826018 | Terminated Phase 1

• 1 other identifier: ALN-HBV-001
• Study Type: interventional
• Target: 24
• Locations: 6 countries
• Sites: 9

Brief Summary

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.

Conditions

Hepatitis B; Chronic Hepatitis B; Hepatitis B, Chronic; Hepatitis B Infection; HBV

Keywords

RNAi therapeutic; Hepatitis B; Chronic Hepatitis B; Hepatitis B, Chronic; Hepatitis B Infection; HBV

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects experiencing adverse events

  Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176

Secondary Outcomes (4)

• Profile of Pharmacokinetics (PK) of ALN-HBV

  Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85

• Profile of Pharmacokinetics (PK) of ALN-HBV

  Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85

• Profile of Pharmacokinetics (PK) of ALN-HBV

  Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85

• Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels

  Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176

Study Arms (2)

ALN-HBV

ACTIVE COMPARATOR

Drug: ALN-HBV

Sterile Normal Saline (0.9% NaCl)

PLACEBO COMPARATOR

Drug: Sterile Normal Saline (0.9% NaCl)

Interventions

ALN-HBV DRUG

Ascending doses of ALN-HBV by subcutaneous (sc) injection

ALN-HBV

Sterile Normal Saline (0.9% NaCl) DRUG

Calculated volume to match active comparator

Sterile Normal Saline (0.9% NaCl)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• 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

You may not qualify if:

• All subjects:
• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (9)

Clinical Trial Site

Adelaide, South Australia, Australia

Location

Clinical Trial Site

Fitzroy, Victoria, Australia

Location

Clinical Trial Site

Parkville, Victoria, Australia

Location

Clinical Trial Site

Hong Kong, Hong Kong

Location

Clinical Trial Site

Auckland, New Zealand

Location

Clinical Trial Site

Singapore, Singapore

Location

Clinical Trial Site

Seoul, 03080, South Korea

Location

Clinical Trial Site

Seoul, 05505, South Korea

Location

Clinical Trial Site

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37290591 DERIVED

MeSH Terms

Conditions

Hepatitis B; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Huang, MD

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 7, 2016
• Study Start: June 24, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

KR (2); GB (1); NZ (1); SG (1); AU (3); HK (1)