Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
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
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
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
Sex
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
24/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
24
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/ct2/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/ct2/show/NCT02826018