NCT02207894Recruiting
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI
A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled (High Dose) Immune Tolerance Induction (ITI)
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
This research program is initiated to evaluate and document data on the success of ITI in 300 haemophilia A patients with newly developed or already existing FVIII-inhibitors (also patients who might potentially have failed in earlier ITIs), which will be treated with ITI - preferably high-dose based on individualized product selection, in order to improve management of this potentially devastating complication of haemophilia treatment. In order to investigate the role of in vitro tests on individual ITI success rate in patients undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII concentrates using the following in vitro tests: Batch selection, Thrombin generation assay (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG Subclasses specific for FVIII, Immunogenotyping.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 6 May 2014
- Start date
- Aug 2006
- Primary completion date
- Dec 2027
- Lead sponsor
- Haemophilia Centre Rhine Main
- Diseases
- Haemophilia
- NCT number
- NCT02207894
What you commit to
- Study type: Observational
- Planned participants: 300
- From Aug 2006 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Female
Who the study is looking for
- Based on the decision of the treating physicians in the participating centres, male patients at any age suffering from severe (FVIII activity \< 1%), moderate (FVIII activity \>1% - 5%), or mild (FVIII activity \> 5%) haemophilia A will be included into this post marketing observation if relevant inhibitor levels (\> 0.6 BU) have been detected, or - in case of an inhibitor level \<0.6 BU - with reduced recovery or half-life of FVIII.
- The observation is also open for patients who failed an earlier ITI attempt.
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haemophilia Centre Rhine Main Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.