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SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection

Primary Purpose

Hepatitis D, Chronic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VIR-2218
VIR-3434
NRTI
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis D, Chronic focused on measuring HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female ages 18 -< 70 years
  • Chronic HDV infection for >/= 6 months
  • On NRTI therapy for >/= 2 months at the time of screening

Exclusion Criteria:

  • Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
  • History of significant liver disease from non-HBV or non-HDV etiology
  • History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
  • History of anaphylaxis
  • History of immune complex disease
  • History of autoimmune disorder
  • History or evidence of alcohol or drug abuse
  • Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1a (VIR-2218)

Cohort 1b (VIR-3434)

Cohort 2a (VIR-2218)

Cohort 2b1 (VIR-3434)

Cohort 2b2 (VIR-3434)

Cohort 2c (VIR-2218 + VIR-3434)

Cohort 3 (VIR-3434)

Cohort 4 (NRTI)

Arm Description

Participants will receive multiple doses of VIR-2218 for up to 96 weeks total

Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.

Participants will receive multiple doses of VIR-2218 for 96 weeks.

Participants will receive multiple doses of VIR-3434 for 96 weeks.

Participants will receive multiple doses of VIR-3434 for 96 weeks.

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 96 weeks total

Participants will receive multiple doses of VIR-3434 for 48 or 96 weeks.

Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.

Outcomes

Primary Outcome Measures

Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 (Cohorts 2 and 3 only)
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, and Week 96
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, and Week 96
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, and Week 96
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, and Week 96
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, and Week 96
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, and Week 96
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at each study visit up to Week 96 (for cohorts with VIR-3434)
Change from baseline in liver fibrosis at Week 48 and Week 96
Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96
MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, and Week 96

Full Information

First Posted
July 1, 2022
Last Updated
June 5, 2023
Sponsor
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05461170
Brief Title
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection
Official Title
A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Detailed Description
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, and 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis D, Chronic
Keywords
HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1a (VIR-2218)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 for up to 96 weeks total
Arm Title
Cohort 1b (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.
Arm Title
Cohort 2a (VIR-2218)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 for 96 weeks.
Arm Title
Cohort 2b1 (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for 96 weeks.
Arm Title
Cohort 2b2 (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for 96 weeks.
Arm Title
Cohort 2c (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 96 weeks total
Arm Title
Cohort 3 (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for 48 or 96 weeks.
Arm Title
Cohort 4 (NRTI)
Arm Type
Placebo Comparator
Arm Description
Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
VIR-2218 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
VIR-3434
Intervention Description
VIR-3434 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
NRTI
Intervention Description
NRTI given orally.
Primary Outcome Measure Information:
Title
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 (Cohorts 2 and 3 only)
Time Frame
Up to 24 Weeks
Title
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Up to 118 Weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks
Title
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at each study visit up to Week 96 (for cohorts with VIR-3434)
Time Frame
Up to 96 Weeks
Title
Change from baseline in liver fibrosis at Week 48 and Week 96
Description
Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
Time Frame
Up to 96 Weeks.
Title
Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96
Description
MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
Time Frame
Up to 96 Weeks
Title
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, and Week 96
Time Frame
Up to 96 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ages 18 to < 70 years at screening Chronic HDV infection for >/= 6 months On NRTI therapy for at least 12 weeks prior to day 1 ALT>ULN and < 5x ULN Anti-HBs >10 mIU/mL at screening if only adding a select set of EC Non-cirrhotic and CPT-A cirrhotic Exclusion Criteria: Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. History of significant liver disease from non-HBV or non-HDV etiology History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. History of anaphylaxis History of immune complex disease History of autoimmune disorder History or evidence of alcohol or drug abuse Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Inquiry
Phone
415-654-5281
Email
clinicaltrials@vir.bio
Facility Information:
Facility Name
Investigative Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
E1 1RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection

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