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New hope for rare bleeding disorder: which drug combo works best?

NCT ID NCT01808911

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two drug combinations in 110 adults with acquired hemophilia, a rare condition where the immune system attacks clotting factors, causing severe bleeding. One group received steroids plus cyclophosphamide, the other steroids plus rituximab. The goal was to see which approach better eliminates the harmful antibodies and restores normal clotting, while tracking side effects like infections and major bleeds.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

110 people

The number who actually took part.

Started

May 2012

Finished

Jan 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * men or women * women post-menpausal or with ongoing contraception * 18 years old or more * diagnosis of acquired hemophilia * patient must be insured * patient has provided written informed consent prior to enrolment * patient compliant Exclusion Criteria: * constitutional hemophilia * chemotherapy * ongoing treatment with prednisone \> 20mg further more 1 month * ongoing treatment with prednisone \>0.7 mg/d further more 10 days * thrombocytopenia * leukopenia * chronic disease

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Conditions

The condition(s) this trial relates to.

acquired hemophilia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired haemophilia

Contacts and locations

Locations

  • AP-HM, University Hospital La Conception

    Marseille, 13385, France

  • Europen Hospital of Georges Pompidou (HEGP)

    Paris, 75908, France

  • Hopsital Bretonneau

    Tours, 37044, France

  • Hospital Ambroise Paré

    Boulogne-Billancourt, 92104, France

  • Hospital Archet 1

    Nice, 06202, France

  • Hospital Bichat

    Paris, 75018, France

  • Hospital Cochin

    Paris, 75679, France

  • Hospital Henri Mondor

    Créteil, 94010, France

  • Hospital Jean Verdier

    Bondy, 93140, France

  • Hospital Kremlin-Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hospital Lyon Sud

    Pierre-Bénite, 69495, France

  • Hospital Nord

    Saint-Etienne, 42055, France

  • Hospital Pitié-Salpêtrière

    Paris, 75651, France

  • Hospital Purpan

    Toulouse, 31059, France

  • Hospital Rangueil

    Toulouse, 31059, France

  • Hospital Saint-Louis

    Paris, 75475, France

  • Hospital Sud / Hospital Pontchaillou

    Rennes, 35000, France

  • Hospital of Béziers

    Béziers, 34525, France

  • Regional Center of Haemophilia Treatment (CRTH) de Lorraine

    Nancy, France

  • University Hospital Amiens

    Amiens, 80054, France

  • University Hospital Bocage

    Dijon, 21079, France

  • University Hospital Côte de Nacre

    Caen, 14033, France

  • University Hospital G. Montpied

    Clermont-Ferrand, 63003, France

  • University Hospital Michallon

    Grenoble, 38043, France

  • University Hospital Saint-Eloi

    Montpellier, 34295, France

  • University Hospital of Bordeaux - Hospital Haut-Lévêque

    Pessac, 33604, France

  • University Hospital of Brest - Hospital La cavale Blanche

    Brest, 29609, France

  • University Hospital of Dijon - Hospital Général

    Dijon, 21033, France

  • University Hospital of Nantes, Hospital Hôtel-Dieu

    Nantes, 44093, France

  • University Hospital of Poitiers

    Poitiers, 86021, France

  • University Hospital of Rouen

    Rouen, 76031, France

  • University Regional Hospital Hautepierre

    Strasbourg, 67098, France

  • University Regional Hospital of Lille

    Lille, 59037, France

  • university Hospital of Limoges

    Limoges, 87042, France