Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan) Trials

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Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Lampertico, Pietro

D-LIVR, NCT03719313 / 2018-003167-54: Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

Completed

407

Europe, Canada, US, RoW

Lonafarnib, EBP994, Sarasar, LNF, Ritonavir, Norvir, RTV, PEG IFN-alfa-2a, Pegasys, pegylated interferon-alfa, Placebo Lonafarnib, Placebo Ritonavir

Eiger BioPharmaceuticals

Hepatitis Delta Virus

10/22

03/23

LIMT-2, NCT05070364 / 2021-003665-35: Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

Active, not recruiting

150

Europe, US, RoW

Peginterferon Lambda-1a, Lambda, Peginterferon Lambda, Pegylated Interferon Lambda

Eiger BioPharmaceuticals, Eiger BioPharmaceuticals, Inc.

Hepatitis Delta Virus

06/24

01/25

NATiV3, NCT04849728: A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( )

Recruiting

1000

Europe, Canada, US, RoW

IVA337, Lanifibranor, Placebo

Inventiva Pharma

NASH - Nonalcoholic Steatohepatitis

09/25

09/26

B-Well1, NCT05630807 / 2021-005139-22: Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

Active, not recruiting

981

Europe, Canada, Japan, US, RoW

Bepirovirsen, Placebo

GlaxoSmithKline, GlaxoSmithKline Research & Development Limited

Chronic Hepatitis B, Hepatitis B, Chronic

11/25

05/26

IP-CURE-B, NCT05045261: ANRS HB07 IP-Cure-B Proof of Concept (PoC) Clinical Trial. Educating the Liver Immune Environment Through TLR8 Stimulation Followed by NUC Discontinuation

Recruiting

100

Europe

administration of SLGN in arm C, Discontinuation of NUC treatment in arms B and C

ANRS, Emerging Infectious Diseases, EUCLID Clinical Trial Platform

Hepatitis B, Chronic

06/24

VISTAS, NCT04663308 / 2020-003027-41: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Recruiting

200

Europe, Canada, US, RoW

Volixibat, SHP626, Placebo

Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.

Primary Sclerosing Cholangitis

09/25

12/25

STARLIGHT, NCT06613698: A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

Not yet recruiting

393

Europe, Canada, Japan, US, RoW

GSK4532990, Placebo

GlaxoSmithKline

Liver Diseases, Alcoholic

12/26

03/27

B-UNITED, NCT06537414: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Recruiting

280

Europe, Canada, Japan, US, RoW

Daplusiran/Tomligisiran Dose Level 1, Daplusiran/Tomligisiran Dose Level 2, Bepirovirsen, Placebo

GlaxoSmithKline

Chronic Hepatitis B Virus Infection, Hepatitis B

07/27

NCT05276297 / 2021-003567-10: A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy

Active, not recruiting

174

Europe, RoW

GSK3228836, Bepirovirsen, GSK3528869A, Control

GlaxoSmithKline, GlaxoSmithKline Biologicals

Hepatitis B, Chronic

06/25

B-Sure, NCT04954859 / 2021-000554-26: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants

Recruiting

450

Europe, Canada, Japan, US, RoW

Bepirovirsen, Placebo

GlaxoSmithKline, GlaxoSmithKline Research & Development Limited

Hepatitis B

02/29

NCT05330455: Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection

Recruiting

1/2

Europe, Canada, RoW

GSK3965193, Placebo to match GSK3965193, Bepirovirsen

GlaxoSmithKline

Hepatitis B

01/27

CirB-RNA, NCT03825458: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

Recruiting

N/A

3500

Europe

Blood sampling

Hospices Civils de Lyon

Hepatitis B

06/29

HDV750, NCT06160635: D-SOLVE Cohorts (Cohort a and B)

Recruiting

N/A

750

Europe

Hannover Medical School, Karolinska University Hospital, Karolinska Institutet, Helmholtz Centre for Infection Research, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, National Institute of Infectious Diseases Matei Bals

HDV, HDV Infection, Chronic Liver Disease

09/26

HDV Describe, NCT05723068: Burden of Hepatitis D Virus (HDV) Infection in Italy

Completed

N/A

515

Europe

University of Turin, Italy, Gilead Sciences

Chronic Hepatitis D

06/24

12/24

D-SHIELD, NCT06122285: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy

Recruiting

N/A

100

Europe

Bulevirtide

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hepatitis D

11/23

12/25

BDTc, NCT06372990: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

Recruiting

N/A

300

Europe

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Duke-NUS Medical School (Singapore)

HBV, HBV/HDV

09/25

09/26

SAVE-D, NCT06397859: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Recruiting

N/A

266

Europe

Bulevirtide, Hepcludex

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hepatitis D

06/26

08/26

MPR_BD, NCT06504485: Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

Recruiting

N/A

192

Europe

Bulevirtide

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Parma University Hospital, University of Rome Tor Vergata

Hepatitis D

11/25

12/25

NCT05618145: National Database on Primary Sclerosing Cholangitis (PSC)

Recruiting

N/A

6000

Europe

Clinical information

University of Milano Bicocca

Primary Sclerosing Cholangitis

10/32

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Lampertico, Pietro

D-LIVR, NCT03719313 / 2018-003167-54: Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

Completed

407

Europe, Canada, US, RoW

Lonafarnib, EBP994, Sarasar, LNF, Ritonavir, Norvir, RTV, PEG IFN-alfa-2a, Pegasys, pegylated interferon-alfa, Placebo Lonafarnib, Placebo Ritonavir

Eiger BioPharmaceuticals

Hepatitis Delta Virus

10/22

03/23

LIMT-2, NCT05070364 / 2021-003665-35: Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

Active, not recruiting

150

Europe, US, RoW

Peginterferon Lambda-1a, Lambda, Peginterferon Lambda, Pegylated Interferon Lambda

Eiger BioPharmaceuticals, Eiger BioPharmaceuticals, Inc.

Hepatitis Delta Virus

06/24

01/25

NATiV3, NCT04849728: A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( )

Recruiting

1000

Europe, Canada, US, RoW

IVA337, Lanifibranor, Placebo

Inventiva Pharma

NASH - Nonalcoholic Steatohepatitis

09/25

09/26

B-Well1, NCT05630807 / 2021-005139-22: Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

Active, not recruiting

981

Europe, Canada, Japan, US, RoW

Bepirovirsen, Placebo

GlaxoSmithKline, GlaxoSmithKline Research & Development Limited

Chronic Hepatitis B, Hepatitis B, Chronic

11/25

05/26

IP-CURE-B, NCT05045261: ANRS HB07 IP-Cure-B Proof of Concept (PoC) Clinical Trial. Educating the Liver Immune Environment Through TLR8 Stimulation Followed by NUC Discontinuation

Recruiting

100

Europe

administration of SLGN in arm C, Discontinuation of NUC treatment in arms B and C

ANRS, Emerging Infectious Diseases, EUCLID Clinical Trial Platform

Hepatitis B, Chronic

06/24

VISTAS, NCT04663308 / 2020-003027-41: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Recruiting

200

Europe, Canada, US, RoW

Volixibat, SHP626, Placebo

Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.

Primary Sclerosing Cholangitis

09/25

12/25

STARLIGHT, NCT06613698: A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

Not yet recruiting

393

Europe, Canada, Japan, US, RoW

GSK4532990, Placebo

GlaxoSmithKline

Liver Diseases, Alcoholic

12/26

03/27

B-UNITED, NCT06537414: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Recruiting

280

Europe, Canada, Japan, US, RoW

Daplusiran/Tomligisiran Dose Level 1, Daplusiran/Tomligisiran Dose Level 2, Bepirovirsen, Placebo

GlaxoSmithKline

Chronic Hepatitis B Virus Infection, Hepatitis B

07/27

Active, not recruiting

174

Europe, RoW

GSK3228836, Bepirovirsen, GSK3528869A, Control

GlaxoSmithKline, GlaxoSmithKline Biologicals

Hepatitis B, Chronic

06/25

B-Sure, NCT04954859 / 2021-000554-26: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants

Recruiting

450

Europe, Canada, Japan, US, RoW

Bepirovirsen, Placebo

GlaxoSmithKline, GlaxoSmithKline Research & Development Limited

Hepatitis B

02/29

NCT05330455: Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection

Recruiting

1/2

Europe, Canada, RoW

GSK3965193, Placebo to match GSK3965193, Bepirovirsen

GlaxoSmithKline

Hepatitis B

01/27

CirB-RNA, NCT03825458: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

Recruiting

N/A

3500

Europe

Blood sampling

Hospices Civils de Lyon

Hepatitis B

06/29

HDV750, NCT06160635: D-SOLVE Cohorts (Cohort a and B)

Recruiting

N/A

750

Europe

HDV, HDV Infection, Chronic Liver Disease

09/26

HDV Describe, NCT05723068: Burden of Hepatitis D Virus (HDV) Infection in Italy

Completed

N/A

515

Europe

University of Turin, Italy, Gilead Sciences

Chronic Hepatitis D

06/24

12/24

D-SHIELD, NCT06122285: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy

Recruiting

N/A

100

Europe

Bulevirtide

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hepatitis D

11/23

12/25

BDTc, NCT06372990: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

Recruiting

N/A

300

Europe

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Duke-NUS Medical School (Singapore)

HBV, HBV/HDV

09/25

09/26

SAVE-D, NCT06397859: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Recruiting

N/A

266

Europe

Bulevirtide, Hepcludex

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hepatitis D

06/26

08/26

MPR_BD, NCT06504485: Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

Recruiting

N/A

192

Europe

Bulevirtide

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Parma University Hospital, University of Rome Tor Vergata

Hepatitis D

11/25

12/25

NCT05618145: National Database on Primary Sclerosing Cholangitis (PSC)

Recruiting

N/A

6000

Europe

Clinical information

University of Milano Bicocca

Primary Sclerosing Cholangitis

10/32



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