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

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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

Tracking Information
First Submitted Date  ICMJE July 5, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date September 24, 2018
Study Start Date  ICMJE June 24, 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02826018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • 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)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis B
  • Chronic Hepatitis B
  • Hepatitis B, Chronic
  • Hepatitis B Infection
  • HBV
Intervention  ICMJE
  • Drug: ALN-HBV
    Ascending doses of ALN-HBV by subcutaneous (sc) injection
  • Drug: Sterile Normal Saline (0.9% NaCl)
    Calculated volume to match active comparator
Study Arms  ICMJE
  • Active Comparator: ALN-HBV
    Intervention: Drug: ALN-HBV
  • Placebo Comparator: Sterile Normal Saline (0.9% NaCl)
    Intervention: Drug: Sterile Normal Saline (0.9% NaCl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 3, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
112
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Hong Kong,   Korea, Republic of,   New Zealand,   Singapore,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02826018
Other Study ID Numbers  ICMJE ALN-HBV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alnylam Pharmaceuticals
Study Sponsor  ICMJE Alnylam Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Huang, MD Alnylam Pharmaceuticals
PRS Account Alnylam Pharmaceuticals
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP