DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
63	Idiopathic thrombocytopenic purpura	2

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	JPRN-JapicCTI-153003	01/9/2015		Drug use surveillance of Takecab for Supplement to Helicobacter pylori eradication	Drug use surveillance of Takecab tablets Supplement to Helicobacter pylori eradication	The following diseases in patients for whom H. pylori will be eradicated with triple therapy: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis	Intervention name : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication) Dosage And administration of the intervention : For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care. Control intervention name : null	TAKEDA PHARMACEUTICAL COMPANY LTD.	NULL				BOTH	500	NA	NULL
2	NCT03219723 (ClinicalTrials.gov)	September 1, 2015	9/7/2017	Drug Use Surveillance of Takecab for Supplement to Helicobacter Pylori Eradication	Drug Use Surveillance of Takecab Tablets Supplement to Helicobacter Pylori Eradication	Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other	Drug: Vonoprazan;Drug: Amoxicillin hydrate;Drug: Clarithromycin;Drug: Metronidazole	Takeda	NULL	Completed	N/A	N/A	All	560		Japan

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

JPRN-JapicCTI-153003

01/9/2015

Drug use surveillance of Takecab for Supplement to Helicobacter pylori eradication

Drug use surveillance of Takecab tablets Supplement to Helicobacter pylori eradication

The following diseases in patients for whom H. pylori will be eradicated with triple therapy: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis

Intervention name : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication)
Dosage And administration of the intervention : For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.
Control intervention name : null

TAKEDA PHARMACEUTICAL COMPANY LTD.

NULL

BOTH

500

NULL

NCT03219723
(ClinicalTrials.gov)

September 1, 2015

9/7/2017

Drug Use Surveillance of Takecab for Supplement to Helicobacter Pylori Eradication

Drug Use Surveillance of Takecab Tablets Supplement to Helicobacter Pylori Eradication

Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other

Drug: Vonoprazan;Drug: Amoxicillin hydrate;Drug: Clarithromycin;Drug: Metronidazole

Takeda

NULL

Completed

N/A

All

560

Japan