A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07226206
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPK-8011QQ — DRUG
    Participants will receive IV SPK-8011QQ

Study Details

This study will assess the safety and tolerability of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SPK-8011QQ
    Participants will receive an intravenous (IV) infusion of SPK-8011QQ on Day 1 of the study.

Primary Outcome Measure

Incidence of participants with adverse events (AEs) [ Time Frame: Up to approximately 5 years ]

Central Contacts

  • Reference Study ID Number: XO46084 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Inherited Blood DisordersOrangeCalifornia92868-4748-
Kaiser PermanenteVallejoCalifornia94589-2441-

Find similar trials in Orange, CA

By research site
Center for Inherited Blood Disorders· Orange, CAKaiser Permanente· Vallejo, CA

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