Acquired HaemophiliaNCT00213473
Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study
An observational study of Acquired Haemophilia and Register, run by University Hospital, Rouen at 1 site in France.
Trial summary
the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Haemophilia, Register
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2001to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with Acquired haemophilia
Who may be able to join
- Factor VIIIc < 30% and Factor VIII inhibitor > 1 u Bethesda
Who cannot join
- absence and signed consent, haemophilia A
Trial locations and contacts
1 site in 1 country.
About this study
the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.
- Conditions
- Acquired Haemophilia, Register
- Keywords
- acquired haemophilia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2001
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired HaemophiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herve LEVESQUE, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213473
- Sponsor's protocol ID
- 2001/001/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wootla B, Christophe OD, Mahendra A, Dimitrov JD, Repesse Y, Ollivier V, Friboulet A, Borel-Derlon A, Levesque H, Borg JY, Andre S, Bayry J, Calvez T, Kaveri SV, Lacroix-Desmazes S. Proteolytic antibodies activate factor IX in patients with acquired hemophilia. Blood. 2011 Feb 17;117(7):2257-64. doi: 10.1182/blood-2010-07-296103. Epub 2010 Dec 3.
PubMed 21131590
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study
- ClinicalTrials.gov ID
- NCT00213473
- Acronym / sponsor ID
- 2001/001/HP
- Conditions
- Acquired Haemophilia, Register
- Keywords
- acquired haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- May 2006
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with Acquired haemophilia
Key inclusion criteria (1 listed)
- Factor VIIIc < 30% and Factor VIII inhibitor > 1 u Bethesda
Key exclusion criteria (1 listed)
- absence and signed consent, haemophilia A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 21131590Wootla B, Christophe OD, Mahendra A, Dimitrov JD, Repesse Y, Ollivier V, Friboulet A, Borel-Derlon A, Levesque H, Borg JY, Andre S, Bayry J, Calvez T, Kaveri SV, Lacroix-Desmazes S. Proteolytic antibodies activate factor IX in patients with acquired hemophilia. Blood. 2011 Feb 17;117(7):2257-64. doi: 10.1182/blood-2010-07-296103. Epub 2010 Dec 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herve LEVESQUE, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Haemophilia and Register, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.