DDrare: Database of Drug Development for Rare Diseases

63. 特発性血小板減少性紫斑病
［臨床試験数：311，薬物数：185（DrugBank：39），標的遺伝子数：43，標的パスウェイ数：132］

Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 10-mg dose of E5501 2G tablet; 10-mg dose of E5501 cyclodextrin oral solution; 10-mg dose of E5501 lipid-based oral; 10-mg dose of E5501-P21% powder; AKR-501, YM-477; AMG 531; AMG531; ARGX-113; ATRA; AVATROMBOPAG MALEATE; Alemtuzumab; Alemtuzumab, Rituximab; All-Trans Retinoid Acid(ATRA); Aminophylline; Amoxicillin; Amoxicillin hydrate; Amoxycillin; Anti-CD40L; Anti-CD40LdAb; Anti-D; Atorvastatin; Atorvastatin 10mg; Atorvastatin 20mg; Avatrombopag; Avatrombopag (proposed); Avatrombopag maleate; Avatrombopag tablets; Azathioprine; BMS-986004; BMS-986004 1500 mg IV; BMS-986004 225 mg IV; BMS-986004 675 mg IV; BMS-986004 75 mg IV; BT595; Blinded (Avatrombopoag tablets); Blisibimod; Bortezomib; Caffeic acid tablets; Clarithromycin; Conventional; Corticosteroids (Aprednislon); CsA; Cyclosporin; Cyclosporin A; Cyclosporine; DARATUMUMAB; Danazol; Daratumumab; Decitabine; Dexamethasone; Dexamethasone (1 cycle); Dexamethasone (4 cycles); Dexamethasone Abcur; Dexamethasone and Rituximab; Doptelet; Doptelet 20 mg film-coated tablets; Doxil; E5501; E5501 40 mg 2 x 20-mg tablets, orally, fasted; E5501 40 mg 2 x 20-mg tablets, orally, with food; E5501 40mg 2 x 20-mg tablets, orally, fasted; ELTROMBOPAG; ELTROMBOPAG OLAMINE; Efgartigimod; Efgartigimod alfa; Eltrombopag; Eltrombopag (Revolade); Eltrombopag combining rituximab; Eltrombopag olamine (SB-497115-GR); Eltrombopag olamine, Revolade, Promacta; Eltrombopag oral tablets; FCM; GMA161; Gammaplex; Gammaplex, intravenous immunoglobulin; Glycyrrhetinic Acid; HBM9161 Dose A; HBM9161 Dose B; HUMAN NORMAL IMMUNOGLOBULIN; HUMAN NORMAL IMMUNOGLOBULIN (IV); HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE; HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE; HUMAX-CD38; Hetrombopag; Hetrombopag Olamine; High dose Dexamethasone pulses; Huaiqihuang Granule; Human Immunoglobulin; Human Immunoglobulin G; Human Normal Immunoglobulin; Human Normal Immunoglobulin (iv); Human Normal Immunoglobulin G (IgG > 98% purity); Human immunoglobulin G; Human normal immunoglobulin; Human normal immunoglobulin for intravenous use; I10E; IGIV3I Grifols 10%; IMMUNOGLOBULIN G; INTERLEUKIN 2; IVIG-L; Ig VENA; Ig VENA 100 ml vial; Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set; IgG Next Generation; IgNextGen 10%; Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution; Immunglobulin; Immunoglobulin; Inactivated Trivalent Influenza vaccine; Interleukin 2; LIV-GAMMA SN Inj.; Lansoprazole; Lansoprazole, clarithromycin, amoxycillin; MabThera; Mabthera; Medical Standard of Care for ITP; Methylprednisolone; Metronidazole; NPLATE; NPLATE 500 microgramos polvo para solución inyectable; Nanogam; NewGAM; NewGam; Nplate; Null; Octagam 10%; Octagam® 10%; Open Label (Avatrombopag tablets); Other: RP% Measurement by FCM as a Diagnostic Test for ITP; Other: healthy controls; PF-06755347 intravenous; PF-06755347 subcutaneous; PG2; PRTX-100 (Staphylococcal protein A); Palmitate; Placebo; Prednisolone; Prednisone; Privigen®; Promacta; Proteína recombinante estimulante de la megacariopoyesis; R788; REVOLADE; REVOLADE, PROMACTA; RITUXIMAB; ROMIPLOSTIM; ROZANOLIXIZUMAB; Recombinant Human Thrombopoietin; Recombinant Human Thrombopoietin (rhTPO); Recombinant human thrombopoietin (rh-TPO); Recombinant human thrombopoietin (rhTPO); Relovade; Revolade; Revolade 25 mg film-coated tablets; Revolade 50 mg film-coated tablets; RhTPO; RhTPO in combination with Rituximab; Rituximab; Rituximab [MabThera/Rituxan]; Romiplostim; Romiplostin; Rozanolixizumab; SB-497115; SB-497115-GR; SB-497115-GR 12.5mg; SB-497115-GR 25mg; SB-497115-GR 50 mg; SB497115; SM101; SM101 20mg/mL; SM101 5mg/mL; STAPHYLOCOCCAL PROTEIN A; Sirolimus; Standard of care; Steroids; TAK-079; TPO; Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication); Thrombopoietin; Triple therapy; Tysabri; UCB7665; Vonoprazan; Water; [UCB7665 ]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2010-019987-35-FR (EUCTR)	26/06/2013	09/09/2010	A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim	A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim	Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 2	France;Czech Republic;Spain;Germany;United Kingdom;Italy
2	EUCTR2010-019987-35-CZ (EUCTR)	21/12/2010	26/11/2010	Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim	A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim	Adult immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
3	EUCTR2010-019987-35-DE (EUCTR)	21/10/2010	25/08/2010	Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim	A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim	Adult immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
4	EUCTR2008-004347-10-BG (EUCTR)	14/10/2010	12/05/2010	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland
5	EUCTR2010-019987-35-ES (EUCTR)	22/09/2010	31/08/2010	Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim	Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim	Púrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: NPLATE 500 microgramos polvo para solución inyectable INN or Proposed INN: ROMIPLOSTIM Other descriptive name: ROMIPLOSTIM	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 2	Czech Republic;United Kingdom;Germany;Spain;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2008-004347-10-SI (EUCTR)	12/11/2009	06/10/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
7	EUCTR2008-004347-10-IT (EUCTR)	07/10/2009	16/09/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP.	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP.	Thrombocytopenia associated with ITP MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: NPLATE INN or Proposed INN: ROMIPLOSTIM	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
8	EUCTR2008-004347-10-SE (EUCTR)	09/09/2009	24/06/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
9	EUCTR2008-004347-10-ES (EUCTR)	16/07/2009	05/06/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)?	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)?	Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland
10	EUCTR2008-004347-10-BE (EUCTR)	10/07/2009	29/05/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2008-004347-10-AT (EUCTR)	17/06/2009	06/05/2009	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)	Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-019987-35-FR
(EUCTR)

26/06/2013

09/09/2010

A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim

Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;Czech Republic;Spain;Germany;United Kingdom;Italy

EUCTR2010-019987-35-CZ
(EUCTR)

21/12/2010

26/11/2010

Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim

Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy

EUCTR2010-019987-35-DE
(EUCTR)

21/10/2010

25/08/2010

Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim

Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy

EUCTR2008-004347-10-BG
(EUCTR)

14/10/2010

12/05/2010

Thrombocytopenia associated with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland

EUCTR2010-019987-35-ES
(EUCTR)

22/09/2010

31/08/2010

Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim

Púrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: NPLATE 500 microgramos polvo para solución inyectable
INN or Proposed INN: ROMIPLOSTIM
Other descriptive name: ROMIPLOSTIM

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom;Germany;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-004347-10-SI
(EUCTR)

12/11/2009

06/10/2009

Thrombocytopenia associated with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden

EUCTR2008-004347-10-IT
(EUCTR)

07/10/2009

16/09/2009

Thrombocytopenia associated with ITP
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: NPLATE
INN or Proposed INN: ROMIPLOSTIM

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden

EUCTR2008-004347-10-SE
(EUCTR)

09/09/2009

24/06/2009

Thrombocytopenia associated with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden

EUCTR2008-004347-10-ES
(EUCTR)

16/07/2009

05/06/2009

A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)?

Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland

EUCTR2008-004347-10-BE
(EUCTR)

10/07/2009

29/05/2009

Thrombocytopenia associated with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-004347-10-AT
(EUCTR)

17/06/2009

06/05/2009

Thrombocytopenia associated with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden