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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Aug 2029 to Nov 2031
    • Study completion date: Aug 2029 to May 2032
    • Secondary endpoints revised (10)
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Trial status: Recruiting to Active, Not Recruitingv11 Show 4 more changesShow less
    • Enrollment target: estimated 124 to confirmed 95
    • Eligibility criteria shortened, about 8 words
    • Study description expanded, about 33 words
    • Site details revised at 20 of 20 sites
  4. Site details revised at 2 of 20 sitesv10
  5. Primary and study completion dates: Oct 2026 to Aug 2029v9 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 118 to 124
    • Study sites: 22 to 20
    • Secondary endpoints revised (10)
    • Study title revised
    • Study arms: 8 to 9
    • Study description expanded, about 1 word
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 3 of 22 sitesv8
  2. Secondary endpoints revised (10)v7
  3. Enrollment target: 70 to 118v6 Show 8 more changesShow less
    • Primary endpoints revised (2)
    • Primary and study completion dates: Dec 2026 to Oct 2026
    • Interventions: VIR-2218 (Drug), VIR-3434 (Drug) to NRTI (Drug), VIR-2218 (Drug), VIR-3434 (Drug)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 9 to 10
    • Study description shortened, about 6 words
    • Site details revised at 7 of 22 sites
    • Study arms: 6 to 8
  4. Study sites: 13 to 22v5
  5. Study sites: 1 to 13v4
  6. Start date changed from estimate of Sep 15, 2022 to Sep 17, 2022v3
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Start date: Aug 15, 2022 to Sep 15, 2022
    • Primary endpoints revised (2)
    • Enrollment target: 58 to 70
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 12 words
    • Site details revised
    • Study arms: 5 to 6
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05461170
Lead Sponsor Vir Biotechnology, Inc.
Conditions
(from sponsor)		 Hepatitis D, Chronic
Related terms Hepatitis, Hepatitis D, Hepatitis D, Chronic
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov