Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of VIR-2218 in Healthy Volunteers and Patients With Chronic Hepatitis B

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672188
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief Summary:
This is a phase 1/2 study in which healthy volunteers and subjects with chronic HBV infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: VIR-2218 Drug: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VIR-2218 Drug: VIR-2218
VIR-2218 given by subcutaneous injection

Placebo Comparator: Placebo Drug: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection




Primary Outcome Measures :
  1. Number of subjects with Adverse Events as assessed by CTCAE v5.0 [ Time Frame: Up to 364 days ]
  2. Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings [ Time Frame: Up to 112 days post-dose ]

Secondary Outcome Measures :
  1. PK: maximum plasma concentration (ng/mL) [ Time Frame: Up to 7 days post-dose ]
  2. PK: time to reach maximum plasma concentration (h) [ Time Frame: Up to 7 days post-dose ]
  3. PK: area under the plasma concentration versus time curve (ng*h/mL) [ Time Frame: Up to 7 days post-dose ]
  4. PK: percent of area extrapolated from AUC last to infinity (%) [ Time Frame: Up to 7 days post-dose ]
  5. PK: apparent terminal elimination half-life (h) [ Time Frame: Up to 7 days post-dose ]
  6. PK: apparent plasma clearance (L/h) [ Time Frame: Up to 7 days post-dose ]
  7. PK: apparent volume of distribution (L) [ Time Frame: Up to 7 days post-dose ]
  8. PK (healthy volunteers): fraction eliminated in the urine (mg) [ Time Frame: Up to 7 days post-dose ]
  9. PK (healthy volunteers): renal clearance (L/h) [ Time Frame: Up to 7 days post-dose ]
  10. CHB: Maximum reduction of serum HBsAg from baseline [ Time Frame: Up to 336 days ]
  11. CHB: Number of subjects with serum HBsAg loss at any time point [ Time Frame: Up to 336 days ]
  12. CHB: Number of subjects with sustained serum HBsAg loss for >/= 6 months [ Time Frame: Up to 336 days ]
  13. CHB: Number of subjects with anti-HBs seroconversion at any timepoint [ Time Frame: Up to 336 days ]
  14. CHB: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint [ Time Frame: Up to 336 days ]


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

Healthy Volunteers:

Inclusion Criteria:

  • Male or female age 18 - 55
  • BMI 18 - 32 kg/m^2

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
  • History or evidence of drug or alcohol abuse
  • History of intolerance to SC injection

CHB Patients:

Inclusion Criteria:

  • Male or female age 18 - 65
  • BMI 18 - 32 kg/m^2
  • Chronic HBV infection for >/= 6 months

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
  • Significant fibrosis or cirrhosis
  • History or evidence of drug or alcohol abuse
  • History of intolerance to SC injection
  • History of chronic liver disease from any cause other than chronic HBV infection
  • History of hepatic decompensation

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): NCT03672188


Contacts
Layout table for location contacts
Contact: Study Inquiry 415-654-5281 clinicaltrials@vir.bio

Locations
Layout table for location information
Australia, Queensland
Investigative Site Recruiting
Birtinya, Queensland, Australia, 4575
Australia, Victoria
Investigative Site Recruiting
Clayton, Victoria, Australia, 3168
Investigative Site Recruiting
Fitzroy, Victoria, Australia, 3065
Hong Kong
Investigative Site Recruiting
Hong Kong, Hong Kong
Korea, Republic of
Investigative Site Recruiting
Busan, Korea, Republic of, 49241
Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
New Zealand
Investigative Site Recruiting
Auckland, New Zealand, 1010
Investigative Site Recruiting
Auckland, New Zealand, 2025
Thailand
Investigative Site Recruiting
Bangkok, Thailand, 10330
Investigative Site Recruiting
Bangkok, Thailand, 10400
Investigative Site Recruiting
Bangkok, Thailand, 10700
Investigative Site Recruiting
Hat Yai, Thailand, 90110
Investigative Site Recruiting
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals

Layout table for additonal information
Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT03672188    
Other Study ID Numbers: VIR-2218-1001
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Vir Biotechnology, Inc.:
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections