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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons with Severe or Moderate Hemophilia A
EU CTIS ID: 2023-503906-35-00
What this study is testing
To evaluate the safety of multiple doses of NXT007
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male (based on sex at birth)
- Diagnosis of severe (FVIII:C <1 IU/dL) or moderate [FVIII coagulant activity (FVIII:C) between >= 1 IU/dL and <= 5 IU/dL)] congenital hemophilia A (HA) with or without inhibitors against FVIII
- Participants with FVIII inhibitors: participants using recombinant activated factor VII (rFVIIa) or willing to switch to rFVIIa as primary bypassing agent for the treatment of breakthrough bleeds, trauma, or procedures
- Historic local FVIII inhibitor test results being available during screening to confirm any previous inhibitor history and current status
- Participants who previously successfully completed immune tolerance induction (ITI) must have done so at least 5 years before screening and must have no evidence of inhibitor recurrence (permanent or temporary) since. FVIII tolerance defined as < 0.6 bethesda unit (BU)/mL (< 1.0 BU/mL only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) and in vivo recovery (IVR) > 66%
You likely can't join if
- Inherited or acquired bleeding disorders other than congenital HA
- Protein C activity, protein S free antigen, or anti-thrombin III activity levels below the lower limit of the reference range at screening
- At high risk for thrombotic microangiopathy (TMA), including past personal or family history of TMA, in the investigator’s judgment
- Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease
- Personal history of ischemic heart disease, cerebrovascular disease, or diabetes mellitus (for participants =12 and <60 years)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy and to chimeric or humanized antibodies or fusion proteins
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.