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ADAMTS13 in Thrombotic Thrombocytopenic Purpura

NCT ID: NCT00426686

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-04-30

Brief Summary

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Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy defined by the spontaneous formation of platelet thrombi in the microvessels. These platelet microthrombi are responsible for a mechanical hemolytic anemia, a thrombocytopenia and a multivisceral ischemia. TTP is a rare but life-threatening disease in the absence of appropriate treatment (PLASMATHERAPY). The onset of the disease usually occurs in adulthood (MOSCHCOVITZ syndrome) and rarely in childhood (UPSHAW-SCHULMAN syndrome). TTP is either sporadic or recurrent with multiple unpredictable relapses. TTP pathophysiology has remained obscure until a new metalloprotease, ADAMTS13, has been demonstrated to be involved in about 90% of all cases. Physiologically, ADAMTS13 function consists in limiting the size of von Willebrand factor (VWF) multimers and consequently, their hemostatic capacity. A large majority of TTP is associated with a severe deficiency of ADAMTS13. In most cases, ADAMTS13 severe deficiency is acquired via auto-antibodies to ADAMTS13; more rarely, ADAMTS13 deficiency is hereditary via ADAMTS13 gene mutations. ADAMTS13 auto-antibodies are either inhibitory of the catalytic activity or non inhibitory. ADAMTS13 mutations are spread all over the gene.

TTP prognosis is quite heterogeneous. Indeed, in about one third of the patients, TTP is refractory to PLASMATHERAPY and/or chronic relapsing. Until now, TTP prognosis factors are not known. Their identification is however crucial both to adapt the curative treatment of an acute episode (addition of first intention immunosuppressive agents to PLASMATHERAPY) and to prevent relapses.

In this context, the aim of the current project is to identify some ADAMTS13 related prognosis factors in TTP. A national prospective multicenter study including both adult and pediatric patients with TTP related to a severe ADAMTS13 deficiency will be designed over a three-year period. This study will involve our group as the French reference center for ADAMTS13 and 10 clinical departments from various French hospitals. Patients will be tested for ADAMTS13 activity and antigen, ADAMTS13 antibodies and ADAMTS13 gene sequencing. Our main hypothesis is that the inactivation of the ADAMTS13 domains crucial for its catalytic activity, either by inhibitory auto-antibodies (acquired TTP) or by genetic mutations (hereditary TTP) is a major bad prognosis factor.

Detailed Description

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Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy defined by the spontaneous formation of platelet thrombi in the microvessels. These platelet microthrombi are responsible for a mechanical hemolytic anemia, a thrombocytopenia and a multivisceral ischemia. TTP is a rare but life-threatening disease in the absence of appropriate treatment (PLASMATHERAPY). The onset of the disease usually occurs in adulthood (MOSCHCOVITZ syndrome) and rarely in childhood (UPSHAW-SCHULMAN syndrome). TTP is either sporadic or recurrent with multiple unpredictable relapses. TTP pathophysiology has remained obscure until a new metalloprotease, ADAMTS13, has been demonstrated to be involved in about 90% of all cases. Physiologically, ADAMTS13 function consists in limiting the size of von WILLBRAND factor (VWF) multimers and consequently, their hemostatic capacity. A large majority of TTP is associated with a severe deficiency of ADAMTS13 activity leading to the accumulation of ultra large VWF multimers in plasma inducing the formation of platelet microthrombi in the microcirculation. In most cases, ADAMTS13 severe deficiency is acquired via auto-antibodies to ADAMTS13; more rarely, ADAMTS13 deficiency is hereditary via ADAMTS13 gene mutations. ADAMTS13 auto-antibodies are either inhibitory of the catalytic activity or non inhibitory. ADAMTS13 mutations are spread all over the gene.

TTP prognosis is quite heterogeneous. Indeed, in about one third of the patients, TTP is refractory to PLASMATHERAPY and/or chronic relapsing. Until now, TTP prognosis factors are not known. Their identification is however crucial both to adapt the curative treatment of an acute episode (addition of first intention immunosuppressive agents to PLASMATHERAPY) and to prevent relapses.

In this context, the aim of the current project is to identify some ADAMTS13 related prognosis factors in TTP. A national prospective multicenter study including both adult and pediatric patients with TTP related to a severe ADAMTS13 deficiency will be designed over a three-year period. This study will involve our group as the French reference center for ADAMTS13 and about 50 clinical departments from various French hospitals. Patients will be tested for ADAMTS13 activity and antigen, ADAMTS13 antibodies and ADAMTS13 gene sequencing. Our main hypothesis is that the inactivation of the ADAMTS13 domains crucial for its catalytic activity, either by inhibitory auto-antibodies (acquired TTP) or by genetic mutations (hereditary TTP) is a major bad prognosis factor.

Conditions

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Thrombotic Thrombocytopenic Purpura

Keywords

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thrombotic thrombocytopenic purpura prognostic factors ADAMTS13

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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Inclusion Criteria

* clinical suspicion of TTP
* Hemoglobin level \< 10 g/dl (adult) or \< 12 g/dl (child)
* Platelet level \< 150 giga/l
* ADAMTS13 activity \< 5%

Exclusion Criteria

* Cancer
* Organ graft
* HIV infection
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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paul COPPO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Antoire, PARIS

Elie AZOULAY, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Saint Louis Paris

Benoît SCHLEMMER, MD

Role: STUDY_DIRECTOR

Hôpital Saint Louis Paris

Eric OKSENHENDLER, MD

Role: STUDY_DIRECTOR

Hôpital Saint Louis Paris

Fadi FAKHOURI, MD

Role: STUDY_DIRECTOR

Hôpital Necker, PARIS

Jean-Paul MIRA, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Cochin, PARIS

Eric RONDEAU, MD

Role: STUDY_DIRECTOR

Hôpital Tenon, PARIS

Jean-paul VERNANT, MD

Role: STUDY_DIRECTOR

Hôpital la Pitié Salpétrière, PARIS

Nicolas SCHLEINITZ, MD

Role: STUDY_DIRECTOR

CHU Conception, MARSEILLE

Gilles KAPLANSKI, MD, PhD

Role: STUDY_DIRECTOR

CHU Conception, MARSEILLE

Albert BENSMAN, MD

Role: STUDY_DIRECTOR

Hôpital Trousseau, PARIS

Chantal LOIRAT, MD

Role: STUDY_DIRECTOR

Hôpital Robert Debré, PARIS

Brigitte BADER-MEUNIER, MD

Role: STUDY_DIRECTOR

Hôpital Robert Debré, PARIS

Christophe PIGUET, MD

Role: STUDY_DIRECTOR

Hôpital Dupuytren, LIMOGES

Guy PUTET, MD

Role: STUDY_DIRECTOR

Hospices civils de LYON, LYON

Béatrice DUCOT, MD

Role: STUDY_DIRECTOR

INSERM U569 Kremlin Bicêtre, Paris

Agnes VEYRADIER, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Antoine Béclère, CLAMART

Thierry LEBLANC, MD

Role: STUDY_DIRECTOR

Hôpital Saint Louis Paris

Patrick NIAUDET, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Necker, PARIS

Christophe RIDEL, MD

Role: STUDY_DIRECTOR

Hôpital Tenon, PARIS

Pascale POULLIN, MD

Role: STUDY_DIRECTOR

CHU de la Conception, MARSEILLE

arlos FRANGIE, MD

Role: STUDY_DIRECTOR

Hôpital Bicêtre, LE KREMLIN BICETRE

Hélène FRANCOIS, MD

Role: STUDY_DIRECTOR

Hôpital Bicêtre, LE KREMLIN BICETRE

Olivier LAMBOTTE, MD

Role: STUDY_DIRECTOR

Hôpital Bicêtre, LE KREMLIN BICETRE

Dominique BORDESSOULE, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Dupytren, LIMOGES

Stéphane GIRAULT, MD

Role: STUDY_DIRECTOR

Hôpital Dupytren, LIMOGES

Hervé CHAMBOST, MD

Role: STUDY_DIRECTOR

Hôpital de la Timone Enfants, Marseilles

Pierre BORDOGONI, MD, PhD

Role: STUDY_DIRECTOR

Hôpital de Brabois-Hôpital d'Enfants, Vandoeuvre-lès-Nancy

Alexandra SALMON, MD

Role: STUDY_DIRECTOR

Hôpital de Brabois- hôpital d'enfants, Vandoeuvre-lès-Nancy

Laurence CLEMENT, MD

Role: STUDY_DIRECTOR

Hôpital de Brabois-Hôpital d'enfants, Vandoeuvre-lès-Nancy

Christian COMBE, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Pellegrin, Bordeaux

Sandrine MEUNIER, MD

Role: STUDY_DIRECTOR

Hôpital Edouard Heriot, Lyon

Gwenaêlle ROUSSEY, MD

Role: STUDY_DIRECTOR

Hôpital Hotel Dieu, Nantes

Mohammed HAMIDOU, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Hotel Dieu, Nantes

Bernard BONNOTTE, MD, PhD

Role: STUDY_DIRECTOR

Hôpital du Bocage, Dijon

Yves TANTER, MD

Role: STUDY_DIRECTOR

Hôpital du Bocage, Dijon

Jacques POURRAT, MD, PhD

Role: STUDY_DIRECTOR

Hôpital de Rangueil, Toulouse

Marie-Christine THOURET, MD

Role: STUDY_DIRECTOR

CHU de l'Archet 2, Nice

Philippe VANHILLE, MD

Role: STUDY_DIRECTOR

CH de Valenciennes, Valenciennes

Nicolas LIMAL, MD

Role: STUDY_DIRECTOR

Hôpital Henri Mondor, Créteil

Philippe REMY, MD

Role: STUDY_DIRECTOR

Hôpital Henri Mondor, Créteil

Jean-Michel KORACH, MD

Role: STUDY_DIRECTOR

CHG Châlons-en-Champagne, Châlons-en-Champagne

Carine GREIB, MD

Role: STUDY_DIRECTOR

Hôpital Haut-Lévêque, Pesac

Jean-Louis PALLOT, MD

Role: STUDY_DIRECTOR

CHI André Grégoire, Montreuil

Alain WYNCKEL, MD

Role: STUDY_DIRECTOR

CHU de Reims, Reims

Claire CAZALETS, MD

Role: STUDY_DIRECTOR

Hôpital Sud, Rennes

Bertrand DE CAGNY, MD

Role: STUDY_DIRECTOR

CHU d'Amiens, Amiens

Claire PRESNE, MD

Role: STUDY_DIRECTOR

CHU D'Amiens, Amiens

Cécile FOHRER, MD

Role: STUDY_DIRECTOR

Hôpital de Haute-Pierre, Strasbourg

Karin BILGER, MD

Role: STUDY_DIRECTOR

Hôpital de Haute-Pierre, Strasbourg

Bruno LIOURE, MD

Role: STUDY_DIRECTOR

Hôpital de Haute-Pierre, Strasbourg

Raoul HERBRECHT, MD, PhD

Role: STUDY_DIRECTOR

Hôpital de Haute-Pierre, Strasbourg

Dominique PLANTAZ, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Nord, Grenoble

Hubert NIVET, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Gatien de Clovheville, Tours

Emmanuel FLECK, MD

Role: STUDY_DIRECTOR

Hôpital Saint Louis, La Rochelle

Jean-Philippe COINDRE, PH

Role: STUDY_DIRECTOR

Centre Hospitalier du Mans, LE MANS

François MAURIER, PH

Role: STUDY_DIRECTOR

Hôpital Sainte-Blandine Service de Médecine Interne, METZ

Mario OJEDA-URIBE, PH

Role: STUDY_DIRECTOR

Centre Hospitalier Régional de MULHOUSE Hôpital Edouard Muller, Département d'Hématologie, Unité de thérapie cellulaire et greffes, MULHOUSE

Christophe RIDEL, PH

Role: STUDY_DIRECTOR

Hôpital Tenon, Service de Néphrologie et de Transplantation rénale, PARIS

François BRIVET, PH

Role: STUDY_DIRECTOR

Hôpital Antoine Béclère, Service de réanimation médicale, CLAMART

Sylvain LAVOUÉ, PH

Role: STUDY_DIRECTOR

CHU Pontchaillou, Service de maladies infectieuses et réanimation médicale, RENNES

Sébastien CANET, PH

Role: STUDY_DIRECTOR

Centre Hospitalier de Perpignan, Hôpital Saint-Jean, Service de Néphrologie, Hémodialyse, PERPIGNAN

François PROVOT, PH

Role: STUDY_DIRECTOR

Centre Hospitalier Régional Universitaire de Lille, Hôpital Calmette, Pôle de Néphrologie, LILLE

Claude GUYOT, PH

Role: STUDY_DIRECTOR

CHU de Nantes, Hôpital de jour et d'Hémodialyse pédiatrique

Xavier BELENFANT, PH

Role: STUDY_DIRECTOR

CHI André Grégoire de Montreuil, Service de Néphrologie, Diabète et Dialyse, MONTREUIL

Laurent PERARD, PH

Role: STUDY_DIRECTOR

Hôpital Edouard Herriot, Service de Médecine Interne, LYON

Edouard DEVAUD, PH

Role: STUDY_DIRECTOR

CHR de Pontoise Hôpital René Dubos, Service de Médecine Interne- Néphrologie- Dialyse, PONTOISE

Arnaud BUFFIN, PH

Role: STUDY_DIRECTOR

CH CHAMBERY, Service de Pédiatrie, CHAMBERY

Tarik KANOUNI, PH

Role: STUDY_DIRECTOR

CHU Montpellier Hôpital Lapeyronie, Service d'Hématologie et Oncologie médicale, MONTPELLIER

Nicolas GAMBIER, PH

Role: STUDY_DIRECTOR

Hôpital Avicenne, Service de Médecine Interne, BOBIGNY

Alain DEVIDAS, PH

Role: STUDY_DIRECTOR

CH Sud-Francilien- Hôpital Gilles de Corbeil, Service d'Hématologie Clinique, CORBEIL-ESSONNES

Laure FEDERICI, PH

Role: STUDY_DIRECTOR

CH Colmar- Hôpital Pasteur, Service de Médecine Interne, COLMAR

Michel FOULARD, PH

Role: STUDY_DIRECTOR

CHRU de Lille- Hôpital Jeanne de Flandre, Service de Néphrologie pédiatrique, LILLE

Serge BOLOGNA, PH

Role: STUDY_DIRECTOR

Hôpital Brabois Adulte, Service d'Hématologie, VANDOEUVRE-LÈS-NANCYS

Locations

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Hôpital Antoine Béclère

Clamart, , France

Site Status

Countries

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France

References

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Veyradier A, Obert B, Houllier A, Meyer D, Girma JP. Specific von Willebrand factor-cleaving protease in thrombotic microangiopathies: a study of 111 cases. Blood. 2001 Sep 15;98(6):1765-72. doi: 10.1182/blood.v98.6.1765.

Reference Type BACKGROUND
PMID: 11535510 (View on PubMed)

Veyradier A, Obert B, Haddad E, Cloarec S, Nivet H, Foulard M, Lesure F, Delattre P, Lakhdari M, Meyer D, Girma JP, Loirat C. Severe deficiency of the specific von Willebrand factor-cleaving protease (ADAMTS 13) activity in a subgroup of children with atypical hemolytic uremic syndrome. J Pediatr. 2003 Mar;142(3):310-7. doi: 10.1067/mpd.2003.79.

Reference Type BACKGROUND
PMID: 12640381 (View on PubMed)

Veyradier A, Lavergne JM, Ribba AS, Obert B, Loirat C, Meyer D, Girma JP. Ten candidate ADAMTS13 mutations in six French families with congenital thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome). J Thromb Haemost. 2004 Mar;2(3):424-9. doi: 10.1111/j.1538-7933.2004.00623.x.

Reference Type BACKGROUND
PMID: 15009458 (View on PubMed)

Fakhouri F, Vernant JP, Veyradier A, Wolf M, Kaplanski G, Binaut R, Rieger M, Scheiflinger F, Poullin P, Deroure B, Delarue R, Lesavre P, Vanhille P, Hermine O, Remuzzi G, Grunfeld JP. Efficiency of curative and prophylactic treatment with rituximab in ADAMTS13-deficient thrombotic thrombocytopenic purpura: a study of 11 cases. Blood. 2005 Sep 15;106(6):1932-7. doi: 10.1182/blood-2005-03-0848. Epub 2005 Jun 2.

Reference Type BACKGROUND
PMID: 15933059 (View on PubMed)

Ferrari S, Scheiflinger F, Rieger M, Mudde G, Wolf M, Coppo P, Girma JP, Azoulay E, Brun-Buisson C, Fakhouri F, Mira JP, Oksenhendler E, Poullin P, Rondeau E, Schleinitz N, Schlemmer B, Teboul JL, Vanhille P, Vernant JP, Meyer D, Veyradier A; French Clinical and Biological Network on Adult Thrombotic Microangiopathies. Prognostic value of anti-ADAMTS 13 antibody features (Ig isotype, titer, and inhibitory effect) in a cohort of 35 adult French patients undergoing a first episode of thrombotic microangiopathy with undetectable ADAMTS 13 activity. Blood. 2007 Apr 1;109(7):2815-22. doi: 10.1182/blood-2006-02-006064.

Reference Type RESULT
PMID: 17164349 (View on PubMed)

Malak S, Wolf M, Millot GA, Mariotte E, Veyradier A, Meynard JL, Korach JM, Malot S, Bussel A, Azoulay E, Boulanger E, Galicier L, Devaux E, Eschwege V, Gallien S, Adrie C, Schlemmer B, Rondeau E, Coppo P; Reseau d'Etude des Microangiopathies Thrombotiques (TMA-Rare Diseases Reference Center). Human immunodeficiency virus-associated thrombotic microangiopathies: clinical characteristics and outcome according to ADAMTS13 activity. Scand J Immunol. 2008 Sep;68(3):337-44. doi: 10.1111/j.1365-3083.2008.02143.x.

Reference Type RESULT
PMID: 18782260 (View on PubMed)

Loirat C, Girma JP, Desconclois C, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura related to severe ADAMTS13 deficiency in children. Pediatr Nephrol. 2009 Jan;24(1):19-29. doi: 10.1007/s00467-008-0863-5. Epub 2008 Jun 24.

Reference Type RESULT
PMID: 18574602 (View on PubMed)

Hommais A, Rayes J, Houllier A, Obert B, Legendre P, Veyradier A, Girma JP, Ribba AS. Molecular characterization of four ADAMTS13 mutations responsible for congenital thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome). Thromb Haemost. 2007 Sep;98(3):593-9.

Reference Type RESULT
PMID: 17849048 (View on PubMed)

Weisinger J, Bouzid R, Fadlallah J, Provot F, Poullin P, Le Guern V, Ribes D, Martis N, Delmas Y, Chantepie S, Rieu V, Benhamou Y, Choukroun G, Marie M, Dana R, Veyradier A, Joly BS, Coppo P. Immune-mediated thrombotic thrombocytopenic purpura with systemic lupus erythematosus: clinical features and outcome. Lupus Sci Med. 2025 Jul 28;12(2):e001691. doi: 10.1136/lupus-2025-001691.

Reference Type DERIVED
PMID: 40730415 (View on PubMed)

Beranger N, Coppo P, Tsatsaris V, Boisseau P, Provot F, Delmas Y, Poullin P, Vanhoorelbeke K, Veyradier A, Joly BS. Management and follow-up of pregnancy-onset thrombotic thrombocytopenic purpura: the French experience. Blood Adv. 2024 Jan 9;8(1):183-193. doi: 10.1182/bloodadvances.2023011972.

Reference Type DERIVED
PMID: 38039511 (View on PubMed)

Beranger N, Tsatsaris V, Coppo P, Veyradier A, Joly BS. High sFlt-1 (Soluble fms-Like Tyrosine Kinase 1)/PlGF (Placental Growth Factor) Ratio in Pregnancy-Onset Thrombotic Thrombocytopenic Purpura. Hypertension. 2023 Sep;80(9):e140-e142. doi: 10.1161/HYPERTENSIONAHA.123.20987. Epub 2023 May 12. No abstract available.

Reference Type DERIVED
PMID: 37170814 (View on PubMed)

Joly BS, Stepanian A, Leblanc T, Hajage D, Chambost H, Harambat J, Fouyssac F, Guigonis V, Leverger G, Ulinski T, Kwon T, Loirat C, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Child-onset and adolescent-onset acquired thrombotic thrombocytopenic purpura with severe ADAMTS13 deficiency: a cohort study of the French national registry for thrombotic microangiopathy. Lancet Haematol. 2016 Nov;3(11):e537-e546. doi: 10.1016/S2352-3026(16)30125-9. Epub 2016 Oct 3.

Reference Type DERIVED
PMID: 27720178 (View on PubMed)

Mariotte E, Azoulay E, Galicier L, Rondeau E, Zouiti F, Boisseau P, Poullin P, de Maistre E, Provot F, Delmas Y, Perez P, Benhamou Y, Stepanian A, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Epidemiology and pathophysiology of adulthood-onset thrombotic microangiopathy with severe ADAMTS13 deficiency (thrombotic thrombocytopenic purpura): a cross-sectional analysis of the French national registry for thrombotic microangiopathy. Lancet Haematol. 2016 May;3(5):e237-45. doi: 10.1016/S2352-3026(16)30018-7. Epub 2016 Apr 16.

Reference Type DERIVED
PMID: 27132698 (View on PubMed)

Thouzeau S, Capdenat S, Stepanian A, Coppo P, Veyradier A. Evaluation of a commercial assay for ADAMTS13 activity measurement. Thromb Haemost. 2013 Oct;110(4):852-3. doi: 10.1160/TH13-05-0393. Epub 2013 Jul 11. No abstract available.

Reference Type DERIVED
PMID: 23846249 (View on PubMed)

Moatti-Cohen M, Garrec C, Wolf M, Boisseau P, Galicier L, Azoulay E, Stepanian A, Delmas Y, Rondeau E, Bezieau S, Coppo P, Veyradier A; French Reference Center for Thrombotic Microangiopathies. Unexpected frequency of Upshaw-Schulman syndrome in pregnancy-onset thrombotic thrombocytopenic purpura. Blood. 2012 Jun 14;119(24):5888-97. doi: 10.1182/blood-2012-02-408914. Epub 2012 Apr 30.

Reference Type DERIVED
PMID: 22547583 (View on PubMed)

Other Identifiers

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PO51064

Identifier Type: -

Identifier Source: org_study_id