Phase 1 / Phase 2: testing SPK-8011QQ for Hemophilia A
This study will assess the whether it is safe and how hard side effects are to live with of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.
Official registry: https://clinicaltrials.gov/study/NCT07226206 · Hoffmann-La Roche · enrollment listed as 5
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are SPK-8011QQ. The registry lists allocation as na. This study will assess the whether it is safe and how hard side effects are to live with of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.
They plan to enroll about 5 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2b, Single-Arm, Open-Label, Multicenter Study of the Safety of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A
Interventions: SPK-8011QQ
Primary outcome (registry wording): Incidence of participants with adverse events (AEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Men only
- ≥18 years of age at the time of signing the ICF
- Male sex assigned at birth
- No prior history of hypersensitivity or anaphylaxis associated with the administration of any FVIII product
- Have ≥150 exposure days to a FVIII protein product such as recombinant, plasma-derived, or extended half-life FVIII product
- Negative screening test for inhibitor against FVIII (i.e., \<0.6 BU)
- Confirmed negative anti-Spark200 antibodies as documented through central laboratory testing of a serum sample
- Adequate renal function, defined as creatinine clearance ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration formula; patients on dialysis are not eligible for the study
Who the registry excludes
- Are currently undergoing antiviral therapy for chronic hepatitis B or chronic hepatitis C
- Have an inherited or acquired bleeding disorder other than hemophilia A
- Have had prior treatment with a vector or gene transfer agent. Nucleic acid-based vaccines, such as the vaccine for coronavirus disease 2019 (COVID-19), are not considered gene transfer agents
- Are receiving an investigational drug concurrently or have received an investigational drug within 30 days or 5 half-lives of the last investigational drug administration, whichever is longer
- Have a major surgical procedure planned in the 15-month period following SPK-8011QQ infusion
- Are unable (or unwilling) to receive blood or blood products (or any standard-of-care treatment for a life-threatening condition)
Public study contact (from the registry)
Reference Study ID Number: XO46084 https://forpatients.roche.com/ No email attachments.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
6 listed- Center for Inherited Blood Disorders — Orange, California (recruiting)
- University of California San Francisco — San Francisco, California (recruiting)
- Kaiser Permanente — Vallejo, California (recruiting)
- Yale School of Medicine — New Haven, Connecticut (recruiting)
- Newark Beth Israel Medical Center — Newark, New Jersey (recruiting)
- New York Presbyterian Hospital - Weill-Cornell — New York, New York (recruiting)
FAQ about this NCT record
Is NCT07226206 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07226206?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07226206?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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