FindTrial
Sign In

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial - TRIUMPH trial

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42326
Enrollment
5
Registered
2015-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A

Interventions

Patients will be treated with rituximab, MSCs and rFVIII.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with mild, moderate or severe hemophilia A with a current anti-FVIII inhibitor that have failed previous regular ITI, independent of titre height.

Exclusion criteria

Exclusion criteria: - Patients with active, severe or uncontrolled infection - HIV positivity and/or CD4

Design outcomes

Primary

MeasureTime frame
Primary objective is to evaluate the efficacy, safety and feasibility of combined immune modulation with rituximab, ITI and MSCs in terms of eradication of FVIII inhibitory activity in hemophilia A patients.—

Secondary

MeasureTime frame
Secondary endpoints are to evaluate the immune changes during the TRIUMPH protocol in terms of T-cell and B-cell proliferation and modulation, time to Complete Response and Partial Response, time to Relapse and adverse events—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)