DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2011-001354-29-ES (EUCTR)	24/09/2012	19/07/2012	An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) 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]	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE	LFB BIOTECHNOLOGIES	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40		France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy
2	EUCTR2011-001354-29-HU (EUCTR)	09/11/2011	12/10/2011	An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE	LFB BIOTECHNOLOGIES	NULL	Not Recruiting			Female: yes Male: yes	40		France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
3	EUCTR2011-001354-29-IT (EUCTR)	09/11/2011	07/03/2012	An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009) 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]	Product Name: human normal immunoglobulin for intravenous use Product Code: I10E INN or Proposed INN: NA Other descriptive name: NA	LFB BIOTECHNOLOGIES	NULL	Not Recruiting			Female: yes Male: yes	40		Hungary;Spain;Ukraine;Russian Federation;Germany;Italy
4	EUCTR2011-001354-29-DE (EUCTR)	12/10/2011	06/10/2011	An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)	An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)	ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Other descriptive name: human Immunoglobulin	LFB BIOTECHNOLOGIES	NULL	Not Recruiting			Female: yes Male: yes	40		France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
5	NCT00151840 (ClinicalTrials.gov)	October 2001	8/9/2005	Efficacy and Safety of IVIG-L in ITP Patients	Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients	Purpura, Thrombocytopenic, Idiopathic	Drug: IVIG-L	Sanquin	NULL	Completed	18 Years	N/A	Both	20	Phase 3	Poland

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

EUCTR2011-001354-29-ES
(EUCTR)

24/09/2012

19/07/2012

An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)

An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
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]

Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE

LFB BIOTECHNOLOGIES

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy

EUCTR2011-001354-29-HU
(EUCTR)

09/11/2011

12/10/2011

An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)

An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE

LFB BIOTECHNOLOGIES

NULL

Not Recruiting

Female: yes
Male: yes

France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy

EUCTR2011-001354-29-IT
(EUCTR)

09/11/2011

07/03/2012

An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009)
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]

Product Name: human normal immunoglobulin for intravenous use
Product Code: I10E
INN or Proposed INN: NA
Other descriptive name: NA

LFB BIOTECHNOLOGIES

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Spain;Ukraine;Russian Federation;Germany;Italy

EUCTR2011-001354-29-DE
(EUCTR)

12/10/2011

06/10/2011

An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)

An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Other descriptive name: human Immunoglobulin

LFB BIOTECHNOLOGIES

NULL

Not Recruiting

Female: yes
Male: yes

France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy

NCT00151840
(ClinicalTrials.gov)

October 2001

8/9/2005

Efficacy and Safety of IVIG-L in ITP Patients

Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

Purpura, Thrombocytopenic, Idiopathic

Drug: IVIG-L

Sanquin

NULL

Completed

18 Years

N/A

Both

Phase 3

Poland