At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
SPK-9001biological
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.
Gene Therapy, Open-label, Dose-escalation Study of PF-06838435 (SPK-9001) [Adeno-associated Viral Vector With Human Factor IX Gene] in Subjects With Hemophilia B
In Brief
A Phase 2 clinical trial evaluating SPK-9001 for Hemophilia B. Completed, enrolled 15 participants across 10 sites in 2 countries.
Detailed Summary
A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with Hemophilia B.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartNov 2015
Primary CompletionApr 2019
TodayJul 2026
First PostedJun 29, 2015
Enrollment StartNov 18, 2015
Primary CompletionApr 8, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.0 years ago
Interventions
SPK-9001biological
A novel, bioengineered adeno-associated viral vector carrying human factor IX variant