DDrare: Database of Drug Development for Rare Diseases

Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
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 = 11C-ACETATE; 11C-acetate; ACT-064992; ACT-293987; AMBRISENTAN; Acetate; Adempas; Adempas (Riociguat, BAY63-2521); Adempas®; Ambrisentan; Ambrisentan 5 mg; Ammonia; Atorvastatin; BARNASCAN; BAY 63-2521; BAY 63-2521 IR coated tablet 1.0 mg; BAY 63-2521 IR coated tablet 1.5 mg; BAY 63-2521 IR coated tablet 2.0 mg; BAY 63-2521 IR coated tablet 2.5 mg; BAY 63-2521 IR tablet 0.5 mg; BAY 63-2521 IR tablet 1.0 mg; BAY 63-2521 IR tablet 1.5 mg; BAY 63-2521 IR tablet 2.0 mg; BAY 63-2521 IR tablet 2.5 mg; BAY 63-2521 coated tablets 0.5 mg; BAY 63-2521 coated tablets 1 mg; BAY 63-2521 coated tablets 1.5 mg; BAY 63-2521 coated tablets 2 mg; BAY 63-2521 coated tablets 2.5 mg; BAY 63-2521 tablets 0.5 mg; BAY 63-2521 tablets 1 mg; BAY 63-2521 tablets 1.5 mg; BAY 63-2521 tablets 2 mg; BAY 63-2521 tablets 2.5 mg; BAY1237592; BOSENTAN; BPA; Barnascan; Behavioral: respiratory and exercise therapy; Behavioral: respiratory and exercise therapy with supplemental oxygen; Bosentan; Bosentan monohydrate; Cysteine; D-glucose; Diagnostic Test: Endogenous thrombin potential; Diagnostic Test: Light transmission aggregometry; Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Rotational thromboelastometry; Edoxaban; FLUDEOXYGLUCOSE; Fludeoxyglucose; GSK1325760; Glucose; Imatinib; Imatinib mesilate; Iodine; JNJ-67896062 / ACT-064992; MACITENTAN; Macitentan; Macitentan 10 mg; Macitentan tablets; Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb; Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth; MultiHance; N-acetyl cysteine; NS-304; NS-304 Placebo; OXYGEN; Opsumit; Opsumit®; Oxygen; Oxygen, liquid; PH-combination therapy; PH-monotherapy; Placebo; Procedure: Ballon Pulmonary Angioplasty; Procedure: Balloon Pulmonary Angioplasty (BPA); Procedure: NO gas; Procedure: Pulmonary Endarteriectomy; Procedure: Pulmonary endarterectomy; Procedure: Supplemental oxygen via a mask; Procedure: long term oxygen therapy; RIOCIGUAT; Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3); Radiation: Computed tomography lung subtraction iodine mapping; Remodulin; Remodulin (R); Remodulin 10mg/ml 20ml; Remodulin 1mg/ml 20ml; Remodulin 2.5mg/ml 20ml; Remodulin 5mg/ml 20ml; Riociguat; Riociguat (ADEMPAS, BAY63-2521); Riociguat (Adempas, BAY63-2521); Riociguat Oral Tablet; Ro 47-0203; SELEXIPAG; Sauerstoff; Selexipag; TRACLEER; TRACLEER 125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Thrombin; Tracleer; Treprostinil; Treprostinil Sodium; Treprostinil sodium; Uptravi; Volibris; Warfarin; [18F]Fluoro-2-deoxy-2-D-glucose

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	ChiCTR2000032403	2021-01-01	2020-04-27	Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)	Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)	chronic thromboembolic pulmonary hypertension	Riociguat Group:Riociguat;Riociguat+BPA Group:Riociguat and BPA;	Shanghai Pulmonary Hospital	NULL	Pending	18		Both	Riociguat Group:30;Riociguat+BPA Group:30;		China
2	JPRN-jRCTs041200052	22/10/2020	22/10/2020	THERAPY-HYBRID-BPA trial	The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH	chronic thromboembolic pulmonary hypertension CTEPH;D000081029	In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks.	Shimokawahara Hiroto	NULL	Recruiting	>= 18age old	< 85age old	Both	72	Phase 2	Japan
3	NCT04600492 (ClinicalTrials.gov)	October 16, 2020	19/10/2020	THERAPY-HYBRID-BPA Trial	The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty	Hypertension, Pulmonary	Drug: Riociguat Oral Tablet	National Hospital Organization Okayama Medical Center	Bayer Yakuhin, Ltd.	Recruiting	18 Years	85 Years	All	72	Phase 2	Japan
4	ChiCTR2000034995	2019-06-01	2020-07-27	Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy	Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy	pulmonary hypertension	BPA:BPA;Target Drug:Target Drug;BPA+Target Drug:BPA+Target Drug;	The First Affiliated Hospital of Guangzhou Medical University	NULL	Recruiting	20	80	Both	BPA:20;Target Drug:20;BPA+Target Drug:20;	N/A	China
5	JPRN-jRCTs031180239	14/04/2016	12/03/2019	MR BPA study	Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study	Chronic Thromboembolic Pulmonary Hypertension	Group A: BPA treatment BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date. Group B: Riociguat treatment Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date.	Fukuda Keiichi	Kawakami Takashi	Not Recruiting	>= 20age old	<= 80age old	Both	60	N/A	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
6	JPRN-UMIN000019549	2016/04/01	28/10/2015	Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension		Chronic thromboembolic pulmonary hypertension (CTEPH)	Group A: BPA treatment Basically BPA treatment needs to be finished within 4 months from the day of first BPA session Group B: Riociguat treatment First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher). The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat.	Keio University School of Medicine	NULL	Recruiting	20years-old	80years-old	Male and Female	60	Not selected	Japan
7	NCT02634203 (ClinicalTrials.gov)	January 2016	8/12/2015	Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension	Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension	Chronic Thromboembolic Pulmonary Hypertension	Procedure: Balloon Pulmonary Angioplasty (BPA);Drug: Riociguat	Assistance Publique - Hôpitaux de Paris	Bayer	Recruiting	18 Years	80 Years	All	124	N/A	France

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

ChiCTR2000032403

2021-01-01

2020-04-27

Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)

chronic thromboembolic pulmonary hypertension

Riociguat Group:Riociguat;Riociguat+BPA Group:Riociguat and BPA;

Shanghai Pulmonary Hospital

NULL

Pending

Both

Riociguat Group:30;Riociguat+BPA Group:30;

China

JPRN-jRCTs041200052

22/10/2020

THERAPY-HYBRID-BPA trial

The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH

chronic thromboembolic pulmonary hypertension
CTEPH;D000081029

In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks.

Shimokawahara Hiroto

NULL

Recruiting

>= 18age old

< 85age old

Both

Phase 2

Japan

NCT04600492
(ClinicalTrials.gov)

October 16, 2020

19/10/2020

THERAPY-HYBRID-BPA Trial

The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty

Hypertension, Pulmonary

Drug: Riociguat Oral Tablet

National Hospital Organization Okayama Medical Center

Bayer Yakuhin, Ltd.

Recruiting

18 Years

85 Years

All

Phase 2

Japan

ChiCTR2000034995

2019-06-01

2020-07-27

Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy

pulmonary hypertension

BPA:BPA;Target Drug:Target Drug;BPA+Target Drug:BPA+Target Drug;

The First Affiliated Hospital of Guangzhou Medical University

NULL

Recruiting

Both

BPA:20;Target Drug:20;BPA+Target Drug:20;

N/A

China

JPRN-jRCTs031180239

14/04/2016

12/03/2019

MR BPA study

Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study

Chronic Thromboembolic Pulmonary Hypertension

Group A: BPA treatment
BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date.

Group B: Riociguat treatment
Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date.

Fukuda Keiichi

Kawakami Takashi

Not Recruiting

>= 20age old

<= 80age old

Both

N/A

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-UMIN000019549

2016/04/01

28/10/2015

Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension

Chronic thromboembolic pulmonary hypertension (CTEPH)

Group A: BPA treatment

Basically BPA treatment needs to be
finished within 4 months from the day of first BPA session

Group B: Riociguat treatment

First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher).
The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat.

Keio University School of Medicine

NULL

Recruiting

20years-old

80years-old

Male and Female

Not selected

Japan

NCT02634203
(ClinicalTrials.gov)

January 2016

8/12/2015

Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension

Procedure: Balloon Pulmonary Angioplasty (BPA);Drug: Riociguat

Assistance Publique - Hôpitaux de Paris

Bayer

Recruiting

18 Years

80 Years

All

124

N/A

France