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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

Study acronym: AQUAx2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2026 → Jun 2027
See other at-risk trials from MeiraGTx, LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from Dec 2026 to Jun 2027
    • Enrollment target: estimated 276 to confirmed 290
    • Site details revised at 33 of 33 sites
    v15
  2. Study sites: 24 to 33v14
  3. Study sites: 25 to 24v13
  4. Enrollment target: 120 to 276v12 Show 6 more changesShow less
    • Primary and study completion dates: Jul 2025 to Dec 2026
    • Study sites: 22 to 25
    • Interventions: AAV2-hAQP1 Concentration 1 (Genetic), AAV2-hAQP1 Concentration 2 (Genetic), Placebo (Other) to AAV2-hAQP1 Concentration 1 (Genetic), AAV2-hAQP1 Concentration 2 (Genetic), AAV2-hAQP1 Concentration 3 (Genetic), AAV2-hAQP1 Concentration…
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints revised (2)
    • Study arms: 3 to 6
  5. Study sites: 11 to 22v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites revised (11)v10
  2. Site contacts updated at 1 of 11 sitesv9
  3. Study sites: 3 to 11v8
  4. Site contacts updated at 1 of 3 sitesv7
  5. Study sites: 1 to 3v6
  6. Eligibility criteria expanded, about 4 wordsv5
  7. Eligibility criteria expanded, about 15 words
    • Site contact updated
    v4
  8. Re-verified, no change to tracked fieldsv3
  9. Site contact updatedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MeiraGTx, LLC
5 trials monitored
See 1 trial at risk
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Trial Details
NCT Number NCT05926765
Lead Sponsor MeiraGTx, LLC
Conditions
(from sponsor)		 Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Related terms Lymphoma, Follicular
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov