An observational study in Hemophilia A, sponsored by Spark Therapeutics, Inc.. Active, not recruiting at 12 sites in 3 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Spark Therapeutics, Inc. (part of Hoffmann-La Roche) · Observational
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Among 25 studies in Hemophilia A by Hoffmann-La Roche — 5 open to participants now, 8 under way, 4 of them phase 3. Hemophilia A · Hoffmann-La Roche.
Among the 25 studies in Hemophilia A by Hoffmann-La Roche, this one is one of 4 that started in 2018, is one of 4 observational ones, and was the 13th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →5 of the 25 studies in Hemophilia A by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Japan
Ages 0–17
Hoffmann-La Roche · Sites in United States
Ages 18+ · Men only
Hoffmann-La Roche · Sites in United States, Argentina, Austria and 15 more countries
Ages 12+
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 19 more countries
Ages 12+
Hoffmann-La Roche · Sites in United States, Canada, Italy and 3 more countries
Ages 2–59 · Men only
By country, each count listing its studies:
Of the 87 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 31 (36%) stop at 75 or younger; 55 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 4 · Phase 3 12 · Phase 4 2
First in 2012; this study’s year is marked. 4 started in 2018.
This study's enrollment of 29 is below the median of 81 across 310 observational studies indexed under Hemophilia A.
Median enrollment 58 across the 20 interventional studies, 66 across the 4 observational. Of the 15 that completed or were terminated, 12 (80%) have results posted.
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This study is registered under Spark Therapeutics, Inc., one of the names counted as Hoffmann-La Roche. Under that name alone:
Spark Therapeutics, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
2 of the studies in Hemophilia A by Hoffmann-La Roche that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07416526Phase 3Hoffmann-La RocheA Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A | 2027-09-23 |
| NCT05181618Hoffmann-La RocheA Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis | 2026-11-19 |
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Among the 25 studies in Hemophilia A by Hoffmann-La Roche, from their registry updates:
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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.
This study will follow patients with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any prior Spark-sponsored SPK-8011 or SPK-8016 study. Participants will be followed for up to a total of 10 years post infusion (including the time on the dosing study).
Males with hemophilia A, who received a single intravenous administration of SPK-8011 or SPK-8016 in any Spark-sponsored study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational long-term safety follow-up study of participants previously treated with SPK-8011 in any Spark-sponsored SPK-8011 study
Observational long-term safety follow-up study of participants previously treated with SPK-8016 in any Spark-sponsored SPK-8016 study
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 9 years
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to 9 years
Incidence of Coagulation Factor VIII (FVIII) Inhibitor Development
Time frame: Up to 9 years
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 9 years
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 9 years
Number of Participants with Physical Exam Abnormalities
Time frame: Up to 9 years
Started Aug 2018 (actual). Primary completion is estimated for Dec 2032, 172 months after the start.
Of 53 industry-sponsored observational studies under Hemophilia A, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 79. This study's planned 172 months is above that.
Counting every sponsor, half of 131 studies reached it within 45 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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