At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 4 enrolled
Drug / intervention
SPK-8016genetic
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.
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
In Brief
A Phase 2 clinical trial evaluating SPK-8016 for Adeno-Associated Virus (AAV) and 16 related conditions. Completed, enrolled 4 participants across 11 sites.
Detailed Summary
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdeno-Associated Virus (AAV), Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders, Factor VIII (FVIII), Factor VIII (FVIII) Deficiency, Factor VIII (FVIII) Gene, Factor VIII (FVIII) Protein, Genetic Diseases, Inborn, Genetic Diseases, X-Linked, Gene Therapy, Gene Transfer, Hematologic Diseases, Hemorrhagic Disorders, Recombinant, Vector, Inhibitors
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionOct 2020
Study CompletionJan 2023
TodayJul 2026
First PostedNov 8, 2018
Enrollment StartJan 30, 2019
Primary CompletionOct 14, 2020
Study CompletionJan 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.6 years ago
Interventions
SPK-8016genetic
adeno-associated viral vector