NCT03432520Active, not recruiting
Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A
A Multi-Center Evaluation of the Long-Term Safety and Efficacy of Spark-sponsored Gene Therapies in Males With Hemophilia A
Source: ClinicalTrials.gov · Last updated 29 Nov 2024
Brief summary (registry, in English)
This long-term follow-up study will continue to evaluate the long-term safety and efficacy of SPK-8011 and SPK-8016 in males with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any Spark-sponsored SPK-8011 or SPK-8016 study.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 29 (actual)
- First submitted
- 24 Jan 2018
- Start date
- 14 Aug 2018
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Spark Therapeutics, Inc.
- Diseases
- Haemophilia
- NCT number
- NCT03432520
What you commit to
- Study type: Observational
- Participants enrolled: 29
- From 14 Aug 2018 to the primary completion date, 31 Dec 2032
- 12 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participants are excluded from the study if any of the following criteria apply:
- 1.Unable or unwilling to comply with the schedule of visits and study assessments as described in this study protocol.
Who the study is looking for
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Have received a single intravenous administration of SPK-8011 or SPK-8016 in either Study SPK-8011-101 or SPK-8016-101, respectively.
- Understand the purpose and risks of the study and provide signed and dated informed consent before undergoing any study-specific procedures.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital & Monash Medical Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Prince Alfred Hospital Department of Cell & Molecular Therapies Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Pennsylvania State University / Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Truman Medical Centers Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Mississippi Center for Advanced Medicine Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| The Children's Hospital Of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Hemophilia Center of Western Pennsylvania Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.