Engineered recombinant human FGF19 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
94原発性硬化性胆管炎2

94. 原発性硬化性胆管炎


臨床試験数 : 148 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2015-003392-30-NL
(EUCTR)
02/05/201617/12/2015The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC)A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC) PRIMARY SCLEROSING CHOLANGITIS (PSC)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0;Level: HLT;Classification code 10004607;Term: Bile duct infections and inflammations;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;Level: HLGT;Classification code 10004606;Term: Bile duct disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
NGM Biopharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Netherlands;United Kingdom
2EUCTR2015-003392-30-GB
(EUCTR)
18/04/201614/12/2015The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC)A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC) PRIMARY SCLEROSING CHOLANGITIS (PSC)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0;Level: HLT;Classification code 10004607;Term: Bile duct infections and inflammations;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;Level: HLGT;Classification code 10004606;Term: Bile duct disorders;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
NGM Biopharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Netherlands;United Kingdom