Ngm282 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 2 |
| 94 | 原発性硬化性胆管炎 | 3 |
| 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 | NCT02135536 (ClinicalTrials.gov) | May 2014 | 8/5/2014 | Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis | A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103 | Primary Biliary Cirrhosis | Biological: NGM282 | NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Australia;New Zealand |
| 2 | NCT02026401 (ClinicalTrials.gov) | February 2014 | 30/12/2013 | Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Biological: NGM282;Biological: Placebo | NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Australia |
| 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 | EUCTR2015-003392-30-NL (EUCTR) | 02/05/2016 | 17/12/2015 | The 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Netherlands;United Kingdom | ||
| 2 | EUCTR2015-003392-30-GB (EUCTR) | 18/04/2016 | 14/12/2015 | The 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] | NGM Biopharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Netherlands;United Kingdom | |||
| 3 | NCT02704364 (ClinicalTrials.gov) | March 2016 | 29/2/2016 | Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis | 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 | Primary Sclerosing Cholangitis | Biological: NGM282;Other: Placebo | NGM Biopharmaceuticals, Inc | NULL | Completed | 18 Years | 75 Years | All | 62 | Phase 2 | United States;France;Netherlands;United Kingdom |