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Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

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ClinicalTrials.gov Identifier: NCT04507269
Recruitment Status : Active, not recruiting
First Posted : August 11, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Brii Biosciences Limited

Brief Summary:
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Placebo
Drug: Placebo Saline given by subcutaneous injection
Drug: Placebo
Saline given by subcutaneous injection




Primary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: up to 48 weeks ]
  2. Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings [ Time Frame: up to 48 weeks ]

Secondary Outcome Measures :
  1. PK: maximum plasma concentration (ng/mL) [ Time Frame: up to 24 weeks ]
  2. PK: time to reach maximum plasma concentration (h) [ Time Frame: up to 24 weeks ]
  3. PK: area under the plasma concentration versus time curve (ng*h/mL) [ Time Frame: up to 24 weeks ]
  4. PK: percent of area extrapolated from AUC last to infinity (%) [ Time Frame: up to 24 weeks ]
  5. PK: apparent terminal elimination half-life (h) [ Time Frame: up to 24 weeks ]
  6. PK: apparent plasma clearance (L/h) [ Time Frame: up to 24 weeks ]
  7. PK: apparent volume of distribution (L) [ Time Frame: up to 24 weeks ]
  8. Maximum reduction of serum HBsAg from baseline [ Time Frame: up to 16 weeks ]
  9. Number of subjects with serum HBsAg loss [ Time Frame: up to 48 weeks ]
  10. Number of subjects with sustained serum HBsAg loss for >/= 6 months [ Time Frame: up to 48 weeks ]
  11. Number of subjects with anti-HBs seroconversion at any timepoint [ Time Frame: up to 48 weeks ]
  12. For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint [ Time Frame: up to 48 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 18 - 65;
  • Weight ≥ 40 kg to ≤ 125 kg;
  • Chronic HBV infection as defined by a positive serum HBsAg 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): NCT04507269


Locations
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China, Beijing
Investigative Site
Beijing, Beijing, China
China, Jilin
Investigative Site
Changchun, Jilin, China
Sponsors and Collaborators
Brii Biosciences Limited
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals
Investigators
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Study Director: Yao Zhang, MD Brii Biosciences Limited
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Responsible Party: Brii Biosciences Limited
ClinicalTrials.gov Identifier: NCT04507269    
Other Study ID Numbers: VIR-2218-1005
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Brii Biosciences Limited:
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic