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	EUCTR2005-005918-20-FR (EUCTR)	23/12/2008	23/10/2008	Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study	Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study	Immune thrombocytopenic purpura (ITP) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Trade Name: MabThera Product Name: MabThera Other descriptive name: RITUXIMAB	Rikshospitalet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United Kingdom;France;Sweden
2	NCT00475423 (ClinicalTrials.gov)	May 2007	17/5/2007	A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.	An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.	Idiopathic Thrombocytopenic Purpura	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	122	Phase 2	Australia
3	NCT00770562 (ClinicalTrials.gov)	July 2005	9/10/2008	A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)	A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura	Idiopathic Thrombocytopenic Purpura	Drug: rituximab;Drug: Dexamethasone	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	103	Phase 3	Italy
4	EUCTR2005-000859-15-IT (EUCTR)	14/04/2005	20/06/2005	Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.	Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.	Front-line treatment of adult ITP MedDRA version: 6.1;Level: PT;Classification code 10021245	Trade Name: Mabthera INN or Proposed INN: Rituximab Trade Name: Mabthera INN or Proposed INN: Rituximab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
5	NCT00909077 (ClinicalTrials.gov)	August 2004	26/5/2009	The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)	A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)	Idiopathic Thrombocytopenic Purpura	Drug: Dexamethasone;Drug: Dexamethasone and Rituximab	Copenhagen University Hospital at Herlev	NULL	Completed	18 Years	N/A	All	155	Phase 3	Denmark

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

EUCTR2005-005918-20-FR
(EUCTR)

23/12/2008

23/10/2008

Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study

Immune thrombocytopenic purpura (ITP)
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Trade Name: MabThera
Product Name: MabThera
Other descriptive name: RITUXIMAB

Rikshospitalet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

110

Phase 3

United Kingdom;France;Sweden

NCT00475423
(ClinicalTrials.gov)

May 2007

17/5/2007

A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.

Idiopathic Thrombocytopenic Purpura

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

122

Phase 2

Australia

NCT00770562
(ClinicalTrials.gov)

July 2005

9/10/2008

A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura

Drug: rituximab;Drug: Dexamethasone

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

103

Phase 3

Italy

EUCTR2005-000859-15-IT
(EUCTR)

14/04/2005

20/06/2005

Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.

Front-line treatment of adult ITP
MedDRA version: 6.1;Level: PT;Classification code 10021245

Trade Name: Mabthera
INN or Proposed INN: Rituximab
Trade Name: Mabthera
INN or Proposed INN: Rituximab

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

NCT00909077
(ClinicalTrials.gov)

August 2004

26/5/2009

The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

Idiopathic Thrombocytopenic Purpura

Drug: Dexamethasone;Drug: Dexamethasone and Rituximab

Copenhagen University Hospital at Herlev

NULL

Completed

18 Years

N/A

All

155

Phase 3

Denmark