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A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (Piranga)

Primary Purpose

Hepatitis B, Chronic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nucleos(t)ide (NUC)
CpAM (RO7049389)
TLR7 (RO7020531)
siRNA (RO7445482)
PEG-IFN
PD-L1 LNA (RO7191863)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index between 18 and 32 kg/m2 inclusive.
  • Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening.
  • HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening.
  • Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening.
  • Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
  • Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
  • History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
  • History of or suspicion of Hepatocellular Carcinoma (HCC).
  • Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
  • Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
  • Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
  • History of alcohol abuse and/or drug abuse within one year of randomization.
  • History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
  • Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
  • Electrocardiogram (ECG) with clinically significant abnormalities.
  • Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

Sites / Locations

  • Inland Empire Liver Foundation
  • Quest Clinical Research
  • Tokuda Hospital Sofia; Hematology department
  • University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • University of Calgary; HSC- Faculty of Medicine
  • Uni of Alberta Hospital
  • Ottawa Hospital
  • Toronto General Hospital
  • Toronto Liver Centre
  • Hospital San Juan de Dios La Serena
  • Peking University People's Hospital
  • Beijing Friendship Hospital
  • The First Hospital of Jilin University
  • West China Hospital, Sichuan University
  • Nanfang Hospital, Southern Medical University
  • Capital Medical University (CMU) - Beijing Ditan Hospital; Liver Center (Center for Liver Diseases)
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Huashan Hospital, Fudan University
  • Hopital Beaujon; Chir 2
  • Hopital de la Croix-Rousse ? Groupement Hospitalier Nord; Pharmacie / Secteur Essais Cliniques
  • Hopital Brabois Adultes; Service Médecine Interne Hématologie
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • Pusan National University Hospital
  • Inje University Busan Paik Hospital; Clinical Trial Center
  • Chuncheon Sacred Heart Hospital
  • Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.
  • Asan Medical Center / Clinical Trial Center
  • SMG-SNU Boramae Medical Center
  • Seoul National University College of Medicine, Liver Research Institute
  • Auckland Clinical Studies Limited
  • Middlemore Clinical Trials
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Hospital Universitario Puerta de Hierro
  • Hospital Alvaro Cunqueiro; Servicio de Farmacia. Planta -1
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital Montecelo
  • Changhua Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital; Pharmacy
  • China Medical University Hospital; Internal Medicine
  • Taichung Veterans General Hospital
  • National Cheng Kung Univ Hosp
  • National Taiwan University Hospital
  • Hivnat; Thai Red Cross Center
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Royal Liverpool University Hospital
  • King College Hospital NHS Foundation Trust
  • St George's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Nucleos(t)ide (NUC) Control Arm

Core Protein Allosteric Modulator (CpAM; RO7049389) + Toll-like Receptor 7 (TLR7;RO7020531) + NUC

Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC

siRNA (RO7445482) (Dose 2) + NUC

siRNA (RO7445482) + Pegylated Interferon (PEG-IFN) + NUC

siRNA (RO7445482) + CpAM (RO7049389) + NUC

siRNA (RO7445482) + TLR7 (RO7020531) + NUC

siRNA(RO7445482)+ Programmed Death Ligand-1 Locked Nucleic Acid (PD-L1 LNA; RO7191863) + NUC [1]

siRNA (RO7445482) + PD-L1 LNA (RO7191863) + NUC [2]

Arm Description

Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, in line with current CHB treatment guidelines, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7049389 (600 mg once daily [QD]) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg once every other day [QOD]) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 1) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. PEG-IFN will be administered at a dose of 180 μg once weekly (QW) for 48 weeks. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) and RO7049389 (600 mg QD) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 13-24 and Weeks 37-48 (i.e., 2 treatment cycles of 12 weeks' duration each and 42 doses of RO7020531 for each cycle). At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 13-24, in addition to their background NUC therapy for the 24-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 25-36, in addition to their background NUC therapy for the 36-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.

Outcomes

Primary Outcome Measures

Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment)

Secondary Outcome Measures

Percentage of Participants with HBsAg loss
Percentage of Participants with HBsAg seroconversion
Percentage of Participants with Hepatitis B Early Antigen (HBeAg) loss (baseline HBeAg-positive participants).
Percentage of Participants with HBeAg seroconversion (baseline HBeAgpositive participants)
Percentage of Participants with HBV DNA < lower limit of quantification (LLOQ), <200 IU/mL and <2,000 IU/mL
Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL)
Plasma Pharmacokinetics (PK) (TLR7) (IU/mL)
Plasma PK (CpAM) (IU/mL)
Plasma PK (NUC) (IU/mL)
Plasma PK (siRNA) (IU/mL)
Serum PK (PEG-IFN) (IU/mL)
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Anti-siRNA Antibodies
Percentage of Participants with Anti-PEG-IFN Antibodies
Plasma PK PD-L1 LNA
Percentage of Participants with Anti PD-L1 LNA Antibodies

Full Information

First Posted
January 8, 2020
Last Updated
October 18, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04225715
Brief Title
A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Acronym
Piranga
Official Title
A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2020 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nucleos(t)ide (NUC) Control Arm
Arm Type
Active Comparator
Arm Description
Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, in line with current CHB treatment guidelines, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
Core Protein Allosteric Modulator (CpAM; RO7049389) + Toll-like Receptor 7 (TLR7;RO7020531) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7049389 (600 mg once daily [QD]) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg once every other day [QOD]) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 1) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA (RO7445482) (Dose 2) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA (RO7445482) + Pegylated Interferon (PEG-IFN) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. PEG-IFN will be administered at a dose of 180 μg once weekly (QW) for 48 weeks. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA (RO7445482) + CpAM (RO7049389) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) and RO7049389 (600 mg QD) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA (RO7445482) + TLR7 (RO7020531) + NUC
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 13-24 and Weeks 37-48 (i.e., 2 treatment cycles of 12 weeks' duration each and 42 doses of RO7020531 for each cycle). At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA(RO7445482)+ Programmed Death Ligand-1 Locked Nucleic Acid (PD-L1 LNA; RO7191863) + NUC [1]
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 13-24, in addition to their background NUC therapy for the 24-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Arm Title
siRNA (RO7445482) + PD-L1 LNA (RO7191863) + NUC [2]
Arm Type
Experimental
Arm Description
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 25-36, in addition to their background NUC therapy for the 36-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide (NUC)
Intervention Description
Nucleos(t)ide (NUC) will be administered orally
Intervention Type
Drug
Intervention Name(s)
CpAM (RO7049389)
Intervention Description
CpAM (RO7049389) will be administered orally
Intervention Type
Drug
Intervention Name(s)
TLR7 (RO7020531)
Intervention Description
TLR7 (RO7020531) will be administered orally
Intervention Type
Drug
Intervention Name(s)
siRNA (RO7445482)
Intervention Description
siRNA (RO7445482) will be administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
PEG-IFN
Other Intervention Name(s)
Pegasys®
Intervention Description
PEG-IFN will be administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
PD-L1 LNA (RO7191863)
Intervention Description
PD-L1 LNA (RO7191863) will be administered subcutaneously
Primary Outcome Measure Information:
Title
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment)
Time Frame
Up to 72 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with HBsAg loss
Time Frame
Up to 96 weeks
Title
Percentage of Participants with HBsAg seroconversion
Time Frame
Up to 96 weeks
Title
Percentage of Participants with Hepatitis B Early Antigen (HBeAg) loss (baseline HBeAg-positive participants).
Time Frame
Up to 96 weeks
Title
Percentage of Participants with HBeAg seroconversion (baseline HBeAgpositive participants)
Time Frame
Up to 96 weeks
Title
Percentage of Participants with HBV DNA < lower limit of quantification (LLOQ), <200 IU/mL and <2,000 IU/mL
Time Frame
Up to 96 weeks
Title
Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL)
Time Frame
Up to 96 weeks
Title
Plasma Pharmacokinetics (PK) (TLR7) (IU/mL)
Time Frame
Up to 48 weeks
Title
Plasma PK (CpAM) (IU/mL)
Time Frame
Up to 48 weeks
Title
Plasma PK (NUC) (IU/mL)
Time Frame
Up to 48 weeks
Title
Plasma PK (siRNA) (IU/mL)
Time Frame
Up to 48 weeks
Title
Serum PK (PEG-IFN) (IU/mL)
Time Frame
Up to 48 weeks
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to 96 weeks
Title
Percentage of Participants with Anti-siRNA Antibodies
Time Frame
Up to 96 weeks
Title
Percentage of Participants with Anti-PEG-IFN Antibodies
Time Frame
Up to 96 weeks
Title
Plasma PK PD-L1 LNA
Time Frame
Up to 37 weeks
Title
Percentage of Participants with Anti PD-L1 LNA Antibodies
Time Frame
Up to 85 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index between 18 and 32 kg/m2 inclusive. Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening. HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening. Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening. Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods. Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. Exclusion Criteria: Pregnant or lactating women. Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV). History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease. History of or suspicion of Hepatocellular Carcinoma (HCC). Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests. Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study. Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study. History of alcohol abuse and/or drug abuse within one year of randomization. History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment. Currently taking, or have received within 3 months of Day 1, systemic corticosteroids. Electrocardiogram (ECG) with clinically significant abnormalities. Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Tokuda Hospital Sofia; Hematology department
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
University of Calgary; HSC- Faculty of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Uni of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Hospital San Juan de Dios La Serena
City
La Serena
ZIP/Postal Code
1700000
Country
Chile
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Capital Medical University (CMU) - Beijing Ditan Hospital; Liver Center (Center for Liver Diseases)
City
Hangzhou City
ZIP/Postal Code
310003
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Facility Name
Hopital Beaujon; Chir 2
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital de la Croix-Rousse ? Groupement Hospitalier Nord; Pharmacie / Secteur Essais Cliniques
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Brabois Adultes; Service Médecine Interne Hématologie
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital; Clinical Trial Center
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Chuncheon Sacred Heart Hospital
City
Gangwon-Do
ZIP/Postal Code
200-704
Country
Korea, Republic of
Facility Name
Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center / Clinical Trial Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Seoul National University College of Medicine, Liver Research Institute
City
Seoul
Country
Korea, Republic of
Facility Name
Auckland Clinical Studies Limited
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro; Servicio de Farmacia. Planta -1
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36212
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital; Pharmacy
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital; Internal Medicine
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung Univ Hosp
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Hivnat; Thai Red Cross Center
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
King College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

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