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	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	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
3	NCT01349790 (ClinicalTrials.gov)	October 2011	5/5/2011	Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia	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	Primary Thrombocytopenia	Drug: NewGam	Octapharma	NULL	Completed	18 Years	65 Years	All	40	Phase 3	Germany
4	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
5	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

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

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

NCT01349790
(ClinicalTrials.gov)

October 2011

5/5/2011

Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia

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

Primary Thrombocytopenia

Drug: NewGam

Octapharma

NULL

Completed

18 Years

65 Years

All

Phase 3

Germany

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