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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02826018




Registration number
NCT02826018
Ethics application status
Date submitted
5/07/2016
Date registered
7/07/2016
Date last updated
24/09/2018

Titles & IDs
Public title
A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
Scientific 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
Secondary ID [1] 0 0
ALN-HBV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Chronic Hepatitis B 0 0
Hepatitis B, Chronic 0 0
Hepatitis B Infection 0 0
HBV 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALN-HBV
Treatment: Drugs - Sterile Normal Saline (0.9% NaCl)

Active Comparator: ALN-HBV -

Placebo Comparator: Sterile Normal Saline (0.9% NaCl) -


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

Treatment: Drugs: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects experiencing adverse events
Timepoint [1] 0 0
Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176
Secondary outcome [1] 0 0
Profile of Pharmacokinetics (PK) of ALN-HBV - Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Secondary outcome [2] 0 0
Profile of Pharmacokinetics (PK) of ALN-HBV - Elimination half-life (t1/2)
Timepoint [2] 0 0
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Secondary outcome [3] 0 0
Profile of Pharmacokinetics (PK) of ALN-HBV - Area under the concentration-time curve (AUC)
Timepoint [3] 0 0
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Secondary outcome [4] 0 0
Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels - Change in HBsAg levels from baseline
Timepoint [4] 0 0
Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Clinical Trial Site - Adelaide
Recruitment hospital [2] 0 0
Clinical Trial Site - Fitzroy
Recruitment hospital [3] 0 0
Clinical Trial Site - Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alnylam Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02826018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Huang, MD
Address 0 0
Alnylam Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02826018