51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | NCT03053739 (ClinicalTrials.gov) | December 2016 | 29/12/2016 | To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Associated Pulmonary Arterial Hypertension | Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India |
| 2 | NCT02798055 (ClinicalTrials.gov) | September 30, 2016 | 3/6/2016 | Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis | A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment. | Systematic Sclerosis;Digital Ulcer;Scleroderma | Drug: Bosentan group | Elpen Pharmaceutical Co. Inc. | NULL | Completed | 18 Years | 80 Years | All | 148 | Greece | |
| 3 | EUCTR2014-002796-28-NL (EUCTR) | 12/04/2016 | 23/04/2015 | Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? | The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS | Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | University Medical Center Groningen (UMCG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 4 | NCT02480335 (ClinicalTrials.gov) | June 26, 2015 | 15/6/2015 | The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis | The Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital Ulcers | Scleroderma, Systemic | Drug: bosentan | University Medical Center Groningen | Actelion | Completed | 18 Years | N/A | All | 20 | Phase 4 | Netherlands |
| 5 | JPRN-JapicCTI-132176 | 01/6/2013 | Bosentan DU | A prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) | Digital ulcers associated with systemic sclerosis | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : Bosentan Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | BOTH | 20 | Phase 3 | NULL | |||
| 6 | EUCTR2011-005303-32-NL (EUCTR) | 05/03/2012 | 26/01/2012 | The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II) | Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II) - HOME II | Digital Ulcera in Systemic Sclerodermia patients MedDRA version: 14.1;Level: PT;Classification code 10053400;Term: Endothelin increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Nederland bv | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 7 | NCT01395732 (ClinicalTrials.gov) | March 2011 | 6/7/2011 | Bosentan in Systemic Sclerosis | Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 4 | Netherlands |
| 8 | NCT01241383 (ClinicalTrials.gov) | December 2010 | 12/11/2010 | Effect of Bosentan in Scleroderma Renal Crisis | Effect of Bosentan in the Course of Scleroderma Renal Crisis | Scleroderma Renal Crisis | Drug: Bosentan | Assistance Publique - Hôpitaux de Paris | Actelion | Completed | 18 Years | N/A | Both | 16 | Phase 2 | France |
| 9 | EUCTR2010-021452-26-FR (EUCTR) | 20/09/2010 | 09/07/2010 | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Les patients inclus dans l'étude seront des patients atteints de sclérodermie systémique (définie selon les critères de la classification de l'ACR et/ou de Leroy et Medsger) et présentant une crise rénale sclérodermique aigue définie par une HTA sévère d'emblée et/ou d'aggravation progressive >150/85mmHg obtenue à deux reprises minimum en 24H, sans autre explication que la ScS et/ou une insuffisance rénale rapidement progressive, sans autre explication que la ScS. MedDRA version: 8.1;Level: PT;Classification code 10062553;Term: scleroderma renal crisis | Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: bosentan Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 10 | NCT00909337 (ClinicalTrials.gov) | January 2008 | 27/5/2009 | Early Therapy of Pulmonary Arterial Hypertension | Early Therapy of Pulmonary Arterial Hypertension | Pulmonary Hypertension;Systemic Sclerosis | Drug: Bosentan | Medical University of Graz | Actelion | Completed | 18 Years | 90 Years | Both | 10 | N/A | Austria |
| 11 | NCT00377455 (ClinicalTrials.gov) | September 2006 | 14/9/2006 | Placebo Controlled Trial of Bosentan in Scleroderma Patients | Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension | Systemic Scleroderma;Pulmonary Hypertension | Drug: Bosentan;Drug: Placebo | Georgetown University | Actelion | Terminated | 18 Years | N/A | All | 5 | Phase 2 | United States |
| 12 | NCT00318175 (ClinicalTrials.gov) | June 2006 | 24/4/2006 | Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis | Study to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF) | Systemic Scleroderma;Skin Fibrosis;Hand Functionality | Drug: Bosentan (Tracleer) | Heinrich-Heine University, Duesseldorf | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | Germany |
| 13 | EUCTR2005-000701-61-GB (EUCTR) | 29/11/2005 | 27/10/2005 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | Scleroderma renal crisis | Trade Name: Tracleer Product Name: Bosentan Product Code: N/A | University College London | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 14 | EUCTR2004-000632-82-IT (EUCTR) | 06/04/2005 | 15/03/2007 | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis Level: PTClassification code 10059084 | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Italy | |||
| 15 | NCT00226889 (ClinicalTrials.gov) | January 2005 | 23/9/2005 | Treatment of Early Systemic Sclerosis by Bosentan | Systemic Sclerosis (Scleroderma) | Drug: bosentan | Rikshospitalet University Hospital | NULL | Terminated | 18 Years | 70 Years | Both | 30 | Phase 1/Phase 2 | Norway | |
| 16 | EUCTR2004-000632-82-GB (EUCTR) | 16/09/2004 | 11/02/2005 | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom | ||
| 17 | EUCTR2004-000631-28-IT (EUCTR) | 14/09/2004 | 17/09/2004 | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Interstitial lung disease associated with systemic sclerosis | Trade Name: TRACLEER*125MG 56CPR RIV. Product Name: NA Product Code: NA INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 18 | NCT00319696 (ClinicalTrials.gov) | July 8, 2004 | 27/4/2006 | Bosentan in Digital Ulcers | Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers | Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg | Actelion | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom |
| 19 | NCT00319033 (ClinicalTrials.gov) | July 2004 | 26/4/2006 | Open-label Study With Bosentan in Interstitial Lung Disease | Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330. | Interstitial Lung Disease;Scleroderma | Drug: bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;Canada;France;Germany;Israel;Italy;Korea, Republic of;Netherlands;Sweden;Switzerland;United Kingdom |
| 20 | NCT02800993 (ClinicalTrials.gov) | October 2003 | 13/6/2016 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 21 | NCT00077584 (ClinicalTrials.gov) | October 2003 | 10/2/2004 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Digital Ulcers;Systemic Sclerosis | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 22 | NCT00070590 (ClinicalTrials.gov) | July 2003 | 6/10/2003 | Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis | Pulmonary Fibrosis;Scleroderma, Systemic | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom |