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	ChiCTR1900027735	2020-01-01	2019-11-24	Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)	Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)	Adult newly diagnosed immune thrombocytopenia	Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.;	Department of Hematology, Anhui Provincial Hospital	NULL	Pending	18	80	Both	Study group:30;Control group:30;	Phase 4	China
2	NCT02914054 (ClinicalTrials.gov)	October 1, 2016	19/9/2016	Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone	Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM)	ITP;Croticosteroid Therapy	Drug: High dose Dexamethasone pulses;Drug: Prednisone	Isfahan University of Medical Sciences	Adibvira	Completed	18 Years	N/A	All	36	Phase 2;Phase 3	Iran, Islamic Republic of
3	NCT01356511 (ClinicalTrials.gov)	September 2010	17/5/2011	High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)	High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial	Purpura, Thrombocytopenic, Idiopathic	Drug: Prednisone;Drug: Dexamethasone	Shandong University	Chinese Academy of Medical Sciences;Peking Union Medical College Hospital;Ruijin Hospital;Wuhan Union Hospital, China;Tongji Hospital;Shandong University of Traditional Chinese Medicine;Anhui Provincial Hospital;Zhejiang Provincial Hospital of TCM;Second Hospital of Shanxi Medical University;Xinjiang Uygur Autonomous Region People's Hospital;Shenzhen Second People's Hospital	Completed	18 Years	80 Years	Both	261	Phase 4	China
4	EUCTR2008-000417-30-IT (EUCTR)	19/06/2008	11/04/2008	Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207	Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207	ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura	Product Name: Dexamethasone INN or Proposed INN: Dexamethasone Product Name: Prednisone INN or Proposed INN: Prednisone	G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
5	NCT00161564 (ClinicalTrials.gov)	February 2004	8/9/2005	A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone	A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment	Idiopathic Thrombocytopenic Purpura (ITP)	Drug: Rituximab	Weill Medical College of Cornell University	Genentech, Inc.	Withdrawn	12 Years	N/A	All	0	Phase 2	United States

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

ChiCTR1900027735

2020-01-01

2019-11-24

Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)

Adult newly diagnosed immune thrombocytopenia

Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.;

Department of Hematology, Anhui Provincial Hospital

NULL

Pending

Both

Study group:30;Control group:30;

Phase 4

China

NCT02914054
(ClinicalTrials.gov)

October 1, 2016

19/9/2016

Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone

Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM)

ITP;Croticosteroid Therapy

Drug: High dose Dexamethasone pulses;Drug: Prednisone

Isfahan University of Medical Sciences

Adibvira

Completed

18 Years

N/A

All

Phase 2;Phase 3

Iran, Islamic Republic of

NCT01356511
(ClinicalTrials.gov)

September 2010

17/5/2011

High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial

Purpura, Thrombocytopenic, Idiopathic

Drug: Prednisone;Drug: Dexamethasone

Shandong University

Chinese Academy of Medical Sciences;Peking Union Medical College Hospital;Ruijin Hospital;Wuhan Union Hospital, China;Tongji Hospital;Shandong University of Traditional Chinese Medicine;Anhui Provincial Hospital;Zhejiang Provincial Hospital of TCM;Second Hospital of Shanxi Medical University;Xinjiang Uygur Autonomous Region People's Hospital;Shenzhen Second People's Hospital

Completed

18 Years

80 Years

Both

261

Phase 4

China

EUCTR2008-000417-30-IT
(EUCTR)

19/06/2008

11/04/2008

Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207

ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura

Product Name: Dexamethasone
INN or Proposed INN: Dexamethasone
Product Name: Prednisone
INN or Proposed INN: Prednisone

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

NCT00161564
(ClinicalTrials.gov)

February 2004

8/9/2005

A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone

A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment

Idiopathic Thrombocytopenic Purpura (ITP)

Drug: Rituximab

Weill Medical College of Cornell University

Genentech, Inc.

Withdrawn

12 Years

N/A

All

Phase 2

United States