299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170

  
6 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2015-002677-38-BE
(EUCTR)
11/05/201603/03/2016An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;United States;Canada;Belgium;Germany;Italy;United Kingdom
2EUCTR2015-002677-38-DE
(EUCTR)
09/05/201603/11/2015An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;United States;Canada;Belgium;Germany;Italy;United Kingdom
3EUCTR2015-002677-38-IT
(EUCTR)
06/04/201625/11/2015An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy
4EUCTR2015-002677-38-GB
(EUCTR)
04/02/201627/10/2015An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot Recruiting Female: yes
Male: yes
195 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Germany;Italy;United Kingdom
5NCT02443688
(ClinicalTrials.gov)
October 30, 20158/5/2015EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) PatientsA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic FibrosisCystic FibrosisDrug: CTX-4430;Drug: PlaceboCeltaxsys, Inc.NULLCompleted18 Years30 YearsAll200Phase 2United States;Belgium;Canada;France;Germany;Italy;United Kingdom
6NCT01944735
(ClinicalTrials.gov)
September 20136/9/2013Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 in Cystic Fibrosis PatientsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTX-4430 When Administered Orally to Cystic Fibrosis Patients for Fifteen DaysCystic FibrosisDrug: CTX-4430;Drug: PlaceboCeltaxsys, Inc.CelerionCompleted18 Years55 YearsBoth17Phase 1United Kingdom