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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05461170




Registration number
NCT05461170
Ethics application status
Date submitted
1/07/2022
Date registered
18/07/2022

Titles & IDs
Public title
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
Scientific 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)
Secondary ID [1] 0 0
VIR-CHDV-V201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis D, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIR-2218
Treatment: Drugs - VIR-3434
Treatment: Drugs - NRTI

Experimental: Cohort 1a (VIR-2218) - Participants will receive multiple doses of VIR-2218 for up to 96 weeks total.

Experimental: Cohort 1b (VIR-3434) - Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.

Experimental: Cohort 2a (VIR-2218) - Participants will receive multiple doses of VIR-2218 for up to 192 weeks.

Experimental: Cohort 2b1 (VIR-3434) - Participants will receive multiple doses of VIR-3434 for up to 192 weeks.

Experimental: Cohort 2b2 (VIR-3434) - Participants will receive multiple doses of VIR-3434 for up to 192 weeks.

Experimental: Cohort 2c (VIR-2218 + VIR-3434) - Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 192 weeks.

Experimental: Cohort 3 (VIR-3434) - Participants will receive multiple doses of VIR-3434 for up to 192 weeks.

Placebo comparator: Cohort 4 (NRTI) - Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.

Experimental: Cohort 5 (VIR-2218) - Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c.


Treatment: Drugs: VIR-2218
VIR-2218 given by subcutaneous injection

Treatment: Drugs: VIR-3434
VIR-3434 given by subcutaneous injection

Treatment: Drugs: NRTI
NRTI given orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 24 Weeks
Primary outcome [2] 0 0
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 118 Weeks
Secondary outcome [1] 0 0
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, Week 96, Week 144, and Week 192.
Timepoint [1] 0 0
Up to 192 Weeks
Secondary outcome [2] 0 0
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, Week 96, Week 144, and Week 192.
Timepoint [2] 0 0
Up to 192 Weeks
Secondary outcome [3] 0 0
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Timepoint [3] 0 0
Up to 192 Weeks
Secondary outcome [4] 0 0
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Timepoint [4] 0 0
Up to 192 Weeks
Secondary outcome [5] 0 0
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Timepoint [5] 0 0
Up to 192 Weeks
Secondary outcome [6] 0 0
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Timepoint [6] 0 0
Up to 192 Weeks
Secondary outcome [7] 0 0
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 192 (for cohorts with VIR3434)
Timepoint [7] 0 0
Up to 192 Weeks
Secondary outcome [8] 0 0
Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, and Week 192
Timepoint [8] 0 0
Up to 192 Weeks.
Secondary outcome [9] 0 0
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, Week 96, Week 144, and Week 192
Timepoint [9] 0 0
Up to 192 Weeks
Secondary outcome [10] 0 0
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192
Timepoint [10] 0 0
Up to 192 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2029
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Stara Zagora
Country [3] 0 0
France
State/province [3] 0 0
Clichy
Country [4] 0 0
France
State/province [4] 0 0
Pessac
Country [5] 0 0
France
State/province [5] 0 0
Rennes
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Germany
State/province [7] 0 0
Frankfurt
Country [8] 0 0
Germany
State/province [8] 0 0
Hannover
Country [9] 0 0
Germany
State/province [9] 0 0
Tübingen
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Pisa
Country [12] 0 0
Moldova, Republic of
State/province [12] 0 0
Chisinau
Country [13] 0 0
Netherlands
State/province [13] 0 0
Rotterdam
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland
Country [15] 0 0
Romania
State/province [15] 0 0
Bucharest
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Birmingham
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
415-654-5281
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05461170