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


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

  
12 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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agemin
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agemax
Inclusion_
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PhaseCountries
1NCT05530278
(ClinicalTrials.gov)
September 20, 20225/9/2022A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic FibrosisAssessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy VolunteersHealthy VolunteersDrug: Galicaftor;Drug: ABBV-576;Drug: Navocaftor;Drug: MidazolamAbbVieNULLCompleted18 Years65 YearsFemale24Phase 1United States
2EUCTR2019-000750-63-RO
(EUCTR)
24/03/202212/05/2022Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2United States;Serbia;Czechia;Slovakia;Spain;United Kingdom;France;Hungary;Canada;Puerto Rico;Poland;Belgium;Romania;Netherlands
3EUCTR2020-005805-25-BE
(EUCTR)
10/11/202102/07/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Netherlands
4EUCTR2020-005805-25-NL
(EUCTR)
28/10/202123/09/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Slovakia;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand
5NCT04853368
(ClinicalTrials.gov)
September 20, 202119/4/2021Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic FibrosisA Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic Fibrosis (CF)Drug: ABBV-576;Drug: Galicaftor;Drug: Placebo;Drug: Navocaftor;Drug: ABBV-119AbbVieNULLRecruiting18 YearsN/AAll90Phase 2United States;Australia;Belgium;Hungary;Netherlands;New Zealand;Slovakia;United Kingdom;Czechia;Germany
6EUCTR2020-005805-25-HU
(EUCTR)
13/09/202115/07/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary
7EUCTR2019-000750-63-PL
(EUCTR)
15/09/202021/07/2020Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2United States;Serbia;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Poland;Belgium;Netherlands
8EUCTR2019-000750-63-FR
(EUCTR)
15/11/201922/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
189Phase 2Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Romania;Netherlands
9EUCTR2019-000750-63-GB
(EUCTR)
31/10/201926/06/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom
10EUCTR2019-000750-63-NL
(EUCTR)
31/10/201905/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
INN or Proposed INN: TBD
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
189Phase 2Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Netherlands
11EUCTR2019-000750-63-BE
(EUCTR)
27/09/201907/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
189Phase 2Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Romania;Netherlands
12EUCTR2019-000750-63-HU
(EUCTR)
03/09/201901/07/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2Serbia;France;United States;Czech Republic;Hungary;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom