Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 94 of 345 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Alnylam Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02826018
First received: July 5, 2016
Last updated: September 27, 2016
Last verified: September 2016
  Purpose
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 Intervention 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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Alnylam Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Maximum plasma concentration (Cmax)

  • 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 ] [ Designated as safety issue: No ]
    Elimination half-life (t1/2)

  • 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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve (AUC)

  • 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 ] [ Designated as safety issue: No ]
    Change in HBsAg levels from baseline


Estimated Enrollment: 112
Study Start Date: July 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02826018

Contacts
Contact: Alnylam Clinical Trials Hotline 617-575-7400
Contact: Alnylam Clinical Trials Hotline 1-866-330-0326

Locations
Australia, South Australia
Clinical Trial Site Recruiting
Adelaide, South Australia, Australia
Australia, Victoria
Clinical Trial Site Recruiting
Fitzroy, Victoria, Australia
Clinical Trial Site Recruiting
Parkville, Victoria, Australia
New Zealand
Clinical Trial Site Recruiting
Auckland, New Zealand
Singapore
Clinical Trial Site Recruiting
Singapore, Singapore
United Kingdom
Clinical Trial Site Recruiting
London, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
Study Director: Eoin Coakley, MD Alnylam Pharmaceuticals
  More Information

Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02826018     History of Changes
Other Study ID Numbers: ALN-HBV-001 
Study First Received: July 5, 2016
Last Updated: September 27, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Ministry of Health
Singapore: Health Sciences Authority

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

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

ClinicalTrials.gov processed this record on December 06, 2016