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	EUCTR2009-014589-24-FR (EUCTR)	12/06/2013	27/09/2011	NA	Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02	Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: NewGAM Product Code: NewGAM Other descriptive name: IMMUNOGLOBULIN G	Octapharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	95	Phase 3	France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
2	EUCTR2012-000796-16-PL (EUCTR)	17/08/2012	25/06/2012	Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia	PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA	Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	OCTAPHARMA AG	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Czech Republic;Poland;Bulgaria
3	EUCTR2012-000796-16-BG (EUCTR)	18/07/2012	22/05/2012	Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia	PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA	Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	OCTAPHARMA AG	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Czech Republic;Poland;Bulgaria
4	EUCTR2012-000796-16-DE (EUCTR)	09/07/2012	20/03/2012	Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia	PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA	Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	OCTAPHARMA AG	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Germany;Czech Republic;Poland;Bulgaria
5	EUCTR2012-000796-16-CZ (EUCTR)	29/05/2012	04/04/2012	Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia	PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA	Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	OCTAPHARMA AG	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Czech Republic;Poland;Bulgaria;Germany
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	EUCTR2009-014589-24-BG (EUCTR)	04/01/2012	13/09/2011	NA	Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02	Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 3	France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India
7	EUCTR2011-000263-27-BG (EUCTR)	14/11/2011	25/08/2011	An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).	An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP	Chronic 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: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring GmbH	NULL	Not Recruiting			Female: yes Male: yes	150		Serbia;Poland;Turkey;Bulgaria
8	EUCTR2009-014589-24-DE (EUCTR)	22/09/2011	12/04/2011	NA	Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02	Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunglobulin Other descriptive name: IMMUNOGLOBULIN G	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 3	France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
9	EUCTR2009-014589-24-CZ (EUCTR)	02/09/2011	26/04/2011	NA	Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02	Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: immunoglobulin Other descriptive name: IMMUNOGLOBULIN G	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 3	France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
10	EUCTR2011-000263-27-PL (EUCTR)	22/07/2011	08/06/2011	An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).	An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP	Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 15.0;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: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring LLC	NULL	Not Recruiting			Female: yes Male: yes	150		Serbia;Poland;Turkey;Bulgaria
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	EUCTR2005-003552-35-DE (EUCTR)	28/03/2006	13/01/2006	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A	Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245	Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	116		Czech Republic;Germany;France
12	EUCTR2005-003552-35-AT (EUCTR)	20/02/2006	16/01/2006	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A	Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A	Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245	Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	116		France;Czech Republic;Austria;Germany

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

EUCTR2009-014589-24-FR
(EUCTR)

12/06/2013

27/09/2011

Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02

Primary Immune Thrombocytopenia (ITP)
MedDRA version: 14.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: NewGAM
Product Code: NewGAM
Other descriptive name: IMMUNOGLOBULIN G

Octapharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India

EUCTR2012-000796-16-PL
(EUCTR)

17/08/2012

25/06/2012

Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia

PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA

Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

OCTAPHARMA AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Czech Republic;Poland;Bulgaria

EUCTR2012-000796-16-BG
(EUCTR)

18/07/2012

22/05/2012

Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia

PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA

Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

OCTAPHARMA AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Czech Republic;Poland;Bulgaria

EUCTR2012-000796-16-DE
(EUCTR)

09/07/2012

20/03/2012

Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia

PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA

Primary Immune Thrombocytopenia (ITP)
MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

OCTAPHARMA AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;Czech Republic;Poland;Bulgaria

EUCTR2012-000796-16-CZ
(EUCTR)

29/05/2012

04/04/2012

Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia

PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA

Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

OCTAPHARMA AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Czech Republic;Poland;Bulgaria;Germany

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

EUCTR2009-014589-24-BG
(EUCTR)

04/01/2012

13/09/2011

Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: NewGAM
Product Code: NewGAM
INN or Proposed INN: Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India

EUCTR2011-000263-27-BG
(EUCTR)

14/11/2011

25/08/2011

An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).

An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP

Chronic 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: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN

CSL Behring GmbH

NULL

Not Recruiting

Female: yes
Male: yes

150

Serbia;Poland;Turkey;Bulgaria

EUCTR2009-014589-24-DE
(EUCTR)

22/09/2011

12/04/2011

Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: NewGAM
Product Code: NewGAM
INN or Proposed INN: Immunglobulin
Other descriptive name: IMMUNOGLOBULIN G

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India

EUCTR2009-014589-24-CZ
(EUCTR)

02/09/2011

26/04/2011

Product Name: NewGAM
Product Code: NewGAM
INN or Proposed INN: immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India

EUCTR2011-000263-27-PL
(EUCTR)

22/07/2011

08/06/2011

Chronic immune thrombocytopenic purpura (ITP)
MedDRA version: 15.0;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: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN

CSL Behring LLC

NULL

Not Recruiting

Female: yes
Male: yes

150

Serbia;Poland;Turkey;Bulgaria

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

EUCTR2005-003552-35-DE
(EUCTR)

28/03/2006

13/01/2006

Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A

Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245

Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

116

Czech Republic;Germany;France

EUCTR2005-003552-35-AT
(EUCTR)

20/02/2006

16/01/2006

Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A

Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245

Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

116

France;Czech Republic;Austria;Germany