Gsk2330672    (DrugBank: GSK-2330672)

1 disease
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]7

93. Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]    [ 230 clinical trials,   215 drugs,   (DrugBank: 51 drugs),   34 drug target genes,   107 drug target pathways]
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 230 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003158-10-PL
(EUCTR)
22/06/202027/03/2020Linerixibat Long-term Safety and Tolerability StudyLong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Poland;United Kingdom;Japan
2EUCTR2019-003158-10-GB
(EUCTR)
04/06/202004/02/2020Linerixibat Long-term Safety and Tolerability StudyLong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Poland;Japan;United Kingdom
3EUCTR2016-002416-41-PL
(EUCTR)
14/11/201705/09/2017Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;France;Canada;Spain;Poland;Australia;Netherlands;United Kingdom;Japan
4EUCTR2016-002416-41-GB
(EUCTR)
24/03/201719/01/2017Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Poland;Spain;Australia;Netherlands;Japan;United Kingdom
5EUCTR2016-002416-41-ES
(EUCTR)
17/02/201709/12/2016Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 19.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2France;United States;Canada;Spain;Australia;Netherlands;Japan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02966834
(ClinicalTrials.gov)
January 11, 201715/11/2016Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary CholangitisA Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)CholestasisDrug: Placebo;Drug: GSK2330672GlaxoSmithKlineNULLCompleted18 Years80 YearsAll147Phase 2United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom
7NCT01899703
(ClinicalTrials.gov)
March 10, 20143/7/2013A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2330672 Administration in Patients With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusCholestasis, IntrahepaticDrug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acidGlaxoSmithKlineNULLCompleted18 Years75 YearsAll22Phase 2United Kingdom