Liver Cirrhosis, Biliary News

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||||||||||  linerixibat (GSK2330672) / GSK
Enrollment change:  A 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 Pruritus (clinicaltrials.gov) -  Jul 19, 2017
P2, N=22, Completed,  Sponsor: GlaxoSmithKline
N=10 --> 22

||||||||||  bezafibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Trial completion, Combination therapy:  BEZURSO: Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Feb 23, 2017
P3, N=100, Completed,  Sponsor: Assistance Publique - H
N=10 --> 22 Active, not recruiting --> Completed

||||||||||  aldafermin (NGM282) / NGM Biopharma
Trial completion, Phase classification, Enrollment change, Trial primary completion date:  Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Aug 24, 2016
P2b, N=36, Completed,  Sponsor: NGM Biopharmaceuticals, Inc
Active, not recruiting --> Completed Recruiting --> Completed | Phase classification: P2 --> P2b | N=45 --> 36 | Trial primary completion date: Jun 2015 --> Feb 2016

|||||||||| Trial completion: High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) - Jun 10, 2016
P=N/A, N=36, Completed, Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Recruiting --> Completed | Phase classification: P2 --> P2b | N=45 --> 36 | Trial primary completion date: Jun 2015 --> Feb 2016 Active, not recruiting --> Completed

||||||||||  linerixibat (GSK2330672) / GSK
Trial completion, Enrollment change:  A 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 Pruritus (clinicaltrials.gov) -  Feb 5, 2016
P2, N=10, Completed,  Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed Active, not recruiting --> Completed | N=40 --> 10

||||||||||  emtricitabine/tenofovir disoproxil fumarate / Generic mfg., lopinavir/ritonavir / Generic mfg.
Trial completion, Enrollment change:  Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Dec 5, 2015
P=N/A, N=13, Completed,  Sponsor: University of Alberta
Active, not recruiting --> Completed | N=40 --> 10 Active, not recruiting --> Completed | N=80 --> 13

||||||||||  linerixibat (GSK2330672) / GSK
Enrollment closed, Trial primary completion date:  A 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 Pruritus (clinicaltrials.gov) -  Sep 21, 2015
P2, N=40, Active, not recruiting,  Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed | N=80 --> 13 Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2016 --> Oct 2015

||||||||||  Livmarli (maralixibat) / Mirum Pharma
Enrollment change, Trial withdrawal:  CASCADE: An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Aug 1, 2015
P2, N=0, Withdrawn,  Sponsor: Shire
Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2016 --> Oct 2015 N=60 --> 0 | Not yet recruiting --> Withdrawn

||||||||||  linerixibat (GSK2330672) / GSK
Phase classification:  A 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 Pruritus (clinicaltrials.gov) -  Jul 13, 2015
P2, N=40, Recruiting,  Sponsor: GlaxoSmithKline
N=60 --> 0 | Not yet recruiting --> Withdrawn Phase classification: P1 --> P2

||||||||||  linerixibat (GSK2330672) / GSK
Trial primary completion date:  A 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 Pruritus (clinicaltrials.gov) -  Jun 22, 2015
P1, N=40, Recruiting,  Sponsor: GlaxoSmithKline
Phase classification: P1 --> P2 Trial primary completion date: Apr 2015 --> Apr 2016

||||||||||  bezafibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Enrollment closed, Combination therapy:  BEZURSO: Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jun 15, 2015
P3, N=100, Active, not recruiting,  Sponsor: Assistance Publique - H
Trial primary completion date: Apr 2015 --> Apr 2016 Recruiting --> Active, not recruiting

||||||||||  Livmarli (maralixibat) / Mirum Pharma
Trial completion, Combination therapy:  Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Apr 10, 2015
P2, N=66, Completed,  Sponsor: Lumena Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Enrollment closed, Trial primary completion date: High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) - Mar 26, 2015
P=N/A, N=40, Active, not recruiting, Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2014 --> Jul 2015

|||||||||| Trial completion, Trial primary completion date: Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT (clinicaltrials.gov) - Feb 23, 2015
P1, N=22, Completed, Sponsor: University of Aarhus
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2014 --> Jul 2015 Recruiting --> Completed | Trial primary completion date: Dec 2014 --> Sep 2014

||||||||||  linerixibat (GSK2330672) / GSK
Trial primary completion date:  A 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 Pruritus (clinicaltrials.gov) -  Jan 22, 2015
P1, N=40, Recruiting,  Sponsor: GlaxoSmithKline
Recruiting --> Completed | Trial primary completion date: Dec 2014 --> Sep 2014 Trial primary completion date: Dec 2014 --> Apr 2015

||||||||||  aldafermin (NGM282) / NGM Biopharma
Trial completion, Combination therapy:  Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jan 2, 2015
P2, N=45, Completed,  Sponsor: NGM Biopharmaceuticals, Inc
Trial primary completion date: Dec 2014 --> Apr 2015 Recruiting --> Completed

||||||||||  Livmarli (maralixibat) / Mirum Pharma
New P2 trial:  CASCADE: An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Dec 22, 2014
P2, N=60, Not yet recruiting,  Sponsor: Lumena Pharmaceuticals, Inc.

||||||||||  Livmarli (maralixibat) / Mirum Pharma
Enrollment closed, Combination therapy:  Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Dec 5, 2014
P2, N=60, Active, not recruiting,  Sponsor: Lumena Pharmaceuticals, Inc.
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Livmarli (maralixibat) / Mirum Pharma
Trial primary completion date, Combination therapy:  Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Oct 15, 2014
P2, N=60, Recruiting,  Sponsor: Lumena Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Sep 2014 --> Feb 2015

||||||||||  bezafibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Trial primary completion date, Combination therapy:  BEZURSO: Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Oct 2, 2014
P3, N=92, Recruiting,  Sponsor: Assistance Publique - H
Trial primary completion date: Sep 2014 --> Feb 2015 Trial primary completion date: Apr 2015 --> Dec 2016

||||||||||  aldafermin (NGM282) / NGM Biopharma
New P2 trial:  Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  May 8, 2014
P2, N=45, Recruiting,  Sponsor: NGM Biopharmaceuticals, Inc

||||||||||  EB06 / Light Chain Biosci, Edesa Biotech
Trial termination:  Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody (clinicaltrials.gov) -  Apr 2, 2014
P2, N=0, Terminated,  Sponsor: NovImmune SA
Trial primary completion date: Apr 2015 --> Dec 2016 Recruiting --> Terminated

||||||||||  fenofibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Trial withdrawal, Combination therapy:  Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Mar 30, 2014
P2, N=0, Withdrawn,  Sponsor: University of Miami
Recruiting --> Terminated Not yet recruiting --> Withdrawn

||||||||||  fenofibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Enrollment change, Combination therapy:  Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Mar 30, 2014
P2, N=0, Withdrawn,  Sponsor: University of Miami
Not yet recruiting --> Withdrawn N=40 --> 0

||||||||||  aldafermin (NGM282) / NGM Biopharma
Enrollment open, Combination therapy:  Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Mar 19, 2014
P2, N=45, Recruiting,  Sponsor: NGM Biopharmaceuticals, Inc
N=40 --> 0 Not yet recruiting --> Recruiting

||||||||||  linerixibat (GSK2330672) / GSK
Enrollment open:  A 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 Pruritus (clinicaltrials.gov) -  Mar 19, 2014
P1, N=40, Recruiting,  Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial completion:  Initial Study of Rituximab to Treat Primary Biliary Cirrhosis (clinicaltrials.gov) -  Mar 3, 2014
P1/2, N=10, Completed,  Sponsor: University of California, Davis
Not yet recruiting --> Recruiting Recruiting --> Completed

||||||||||  sertraline / Generic mfg.
Trial completion:  Treatment of Cholestatic Pruritus With Sertraline (clinicaltrials.gov) -  Feb 22, 2014
P2, N=40, Completed,  Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruiting --> Completed Recruiting --> Completed

||||||||||  aldafermin (NGM282) / NGM Biopharma
New P2 trial, Combination therapy:  Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jan 1, 2014
P2, N=45, Recruiting,  Sponsor: NGM Biopharmaceuticals, Inc

||||||||||  emtricitabine/tenofovir disoproxil fumarate / Generic mfg., lopinavir/ritonavir / Generic mfg.
Enrollment closed:  Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Nov 10, 2013
P=N/A, N=80, Active, not recruiting,  Sponsor: University of Alberta
Recruiting --> Completed Not yet recruiting --> Active, not recruiting

||||||||||  pentoxifylline / Generic mfg.
Enrollment change:  Pentoxifylline for Primary Biliary Cirrhosis (clinicaltrials.gov) -  Oct 15, 2013
P2, N=20, Completed,  Sponsor: The Cleveland Clinic
Not yet recruiting --> Active, not recruiting N=25 --> 20

||||||||||  pentoxifylline / Generic mfg.
Trial completion:  Pentoxifylline for Primary Biliary Cirrhosis (clinicaltrials.gov) -  Oct 15, 2013
P2, N=20, Completed,  Sponsor: The Cleveland Clinic
N=25 --> 20 Active, not recruiting --> Completed

||||||||||  Stelara (ustekinumab) / J&J
Enrollment change:  A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid (clinicaltrials.gov) -  Sep 8, 2013
P2, N=20, Completed,  Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed N=128 --> 20

||||||||||  Stelara (ustekinumab) / J&J
Trial completion:  A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid (clinicaltrials.gov) -  Sep 8, 2013
P2, N=20, Completed,  Sponsor: Janssen Research & Development, LLC
N=128 --> 20 Recruiting --> Completed

||||||||||  Livmarli (maralixibat) / Mirum Pharma
Enrollment open, Combination therapy:  Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Aug 14, 2013
P2, N=60, Recruiting,  Sponsor: Lumena Pharmaceuticals, Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Livmarli (maralixibat) / Mirum Pharma
New P2 trial, Combination therapy:  Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jul 18, 2013
P2, N=60, Recruiting,  Sponsor: Lumena Pharmaceuticals, Inc.

||||||||||  linerixibat (GSK2330672) / GSK
New P1 trial:  A 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 Pruritus (clinicaltrials.gov) -  Jul 11, 2013
P1, N=40, Recruiting,  Sponsor: GlaxoSmithKline

|||||||||| New P1 trial: Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT (clinicaltrials.gov) - Jun 16, 2013
P1, N=22, Recruiting, Sponsor: University of Aarhus

||||||||||  ursodeoxycholic acid / Generic mfg.
New P3 trial:  Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis (clinicaltrials.gov) -  May 16, 2013
P3, N=216, Completed,  Sponsor: Beijing Friendship Hospital

|||||||||| Trial completion: Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis (clinicaltrials.gov) - Jan 24, 2013
P3, N=29, Completed, Sponsor: University of Michigan
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  bezafibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
Enrollment open, Combination therapy:  BEZURSO: Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Nov 15, 2012
P3, N=92, Recruiting,  Sponsor: Assistance Publique - H
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  bezafibrate / Generic mfg., ursodeoxycholic acid / Generic mfg.
New P3 trial, Combination therapy:  BEZURSO: Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jul 30, 2012
P3, N=92, Recruiting,  Sponsor: Assistance Publique - H

|||||||||| Clinical: High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) - May 20, 2012
P=N/A, N=40, Recruiting, Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

||||||||||  Campath (alemtuzumab) / Sanofi
Trial withdrawal:  Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Apr 8, 2012
P1, N=0, Withdrawn,  Sponsor: Richard Burt, MD
Not yet recruiting --> Recruiting Recruiting --> Withdrawn

||||||||||  Campath (alemtuzumab) / Sanofi
Enrollment change:  Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis (clinicaltrials.gov) -  Apr 8, 2012
P1, N=0, Withdrawn,  Sponsor: Richard Burt, MD
Recruiting --> Withdrawn N=10 --> 0

||||||||||  modafinil / Generic mfg.
Trial completion:  Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC) (clinicaltrials.gov) -  Jan 16, 2012
P1, N=40, Completed,  Sponsor: Mayo Clinic
N=10 --> 0 Active, not recruiting --> Completed

||||||||||  ursodeoxycholic acid / Generic mfg.
New P4 trial:  Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis (clinicaltrials.gov) -  Jan 11, 2012
P4, N=65, Completed,  Sponsor: Dr. Falk Pharma GmbH

||||||||||  EB06 / Light Chain Biosci, Edesa Biotech
New P2 trial:  Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody (clinicaltrials.gov) -  Sep 6, 2011
P2, N=0, Terminated,  Sponsor: NovImmune SA



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