At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
ADVM-043genetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Study of Intravenous or Intrapleural Administration of a Serotype rh.10 Replication Deficient Adeno-associated Virus Gene Transfer Vector Expressing the Human Alpha-1 Antitrypsin cDNA to Individuals With Alpha-1 Antitrypsin Deficiency
In Brief
A Phase 2 clinical trial evaluating ADVM-043 for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 6 participants across 2 sites.
Detailed Summary
The ADVANCE study is being conducted by Adverum Biotechnologies, Inc. as an open-label, multicenter, dose-escalation study in order to assess the safety and protein expression of ADVM-043 following a single intravenous or intrapleural administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha 1-Antitrypsin Deficiency
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartNov 2017
Primary CompletionAug 2019
TodayJul 2026
First PostedJun 20, 2014
Enrollment StartNov 28, 2017
Primary CompletionAug 29, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.0 years ago
Interventions
ADVM-043genetic
Gene transfer vector administration