Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02826018
Recruitment Status : Terminated
First Posted : July 7, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Chronic Hepatitis B Hepatitis B, Chronic Hepatitis B Infection HBV Drug: ALN-HBV Drug: Sterile Normal Saline (0.9% NaCl) Phase 1

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 24, 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ALN-HBV Drug: ALN-HBV
Ascending doses of ALN-HBV by subcutaneous (sc) injection

Placebo Comparator: Sterile Normal Saline (0.9% NaCl) Drug: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator




Primary Outcome Measures :
  1. Proportion of subjects experiencing adverse events [ Time Frame: Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176 ]

Secondary Outcome Measures :
  1. Profile of Pharmacokinetics (PK) of ALN-HBV [ Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85 ]
    Maximum plasma concentration (Cmax)

  2. Profile of Pharmacokinetics (PK) of ALN-HBV [ Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85 ]
    Elimination half-life (t1/2)

  3. Profile of Pharmacokinetics (PK) of ALN-HBV [ Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85 ]
    Area under the concentration-time curve (AUC)

  4. Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels [ Time Frame: Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176 ]
    Change in HBsAg levels from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects:

  • 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

Additional inclusion criteria for patients with HBV infection:

  • Body mass index (BMI) ≥18.0 kg/m2
  • Must be on a stable regimen of entecavir or tenofovir

Exclusion Criteria:

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)

Additional exclusion criteria for healthy volunteers:

  • Evidence of liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826018


Locations
Layout table for location information
Australia, South Australia
Clinical Trial Site
Adelaide, South Australia, Australia
Australia, Victoria
Clinical Trial Site
Fitzroy, Victoria, Australia
Clinical Trial Site
Parkville, Victoria, Australia
Hong Kong
Clinical Trial Site
Hong Kong, Hong Kong
Korea, Republic of
Clinical Trial Site
Seoul, Korea, Republic of, 03080
Clinical Trial Site
Seoul, Korea, Republic of, 05505
New Zealand
Clinical Trial Site
Auckland, New Zealand
Singapore
Clinical Trial Site
Singapore, Singapore
United Kingdom
Clinical Trial Site
London, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Stephen Huang, MD Alnylam Pharmaceuticals

Layout table for additonal information
Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02826018     History of Changes
Other Study ID Numbers: ALN-HBV-001
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

Keywords provided by Alnylam Pharmaceuticals:
RNAi therapeutic
Hepatitis B
Chronic Hepatitis B
Hepatitis B, Chronic
Hepatitis B Infection
HBV

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections