CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
SPK-8011genetic
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Males age 18 years or older
  • ✓Confirmed hemophilia A with baseline FVIII activity ≤2%
  • ✓At least 150 exposure days to FVIII concentrates or cryoprecipitate
  • ✓No prior allergic reaction to any FVIII product
Key exclusion· 6
  • ✕Active hepatitis B or C
  • ✕Currently on antiviral therapy for hepatitis B or C
  • ✕Significant underlying liver disease
  • ✕HIV-1/HIV-2 with CD4 count ≤200/mm³ or uncontrolled viral infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003533
NCT03003533Phase 2Completed
CompareCT.gov

Gene-transfer, Open-label, Dose-escalation Study of SPK-8011 [Adeno-associated Viral Vector With B-domain Deleted Human Factor VIII Gene] in Individuals With Hemophilia A

Spark Therapeutics, Inc.·interventional·Posted Dec 28, 2016·Updated Dec 30, 2024

In Brief

A Phase 2 clinical trial evaluating SPK-8011 for Hemophilia A. Completed, enrolled 25 participants across 16 sites in 5 countries.

Detailed Summary

This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Canada, Israel, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 28, 2016
Enrollment StartJan 26, 2017
Primary CompletionDec 5, 2023
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 9.5 years ago

Interventions

SPK-8011genetic

A novel, bio-engineered, recombinant adeno-associated viral vector carrying human factor VIII gene