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Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (MONARCH)

Primary Purpose

Hepatitis B, Hepatitis D

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ARC-520

entecavir

pegylated interferon alpha 2a

tenofovir disoproxil

antihistamine

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18 to 75 years of age
Written informed consent
No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment
Diagnosis of HBeAg negative or positive chronic HBV infection.
Must be HBsAg (+) during screening.
Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and
Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1
Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners)

Exclusion Criteria:

Pregnant or lactating
Acute signs of hepatitis/other severe infections within 4 weeks of screening
Use within the last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants
Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives
History of poorly controlled autoimmune disease or any history of autoimmune hepatitis
History of heterozygous or homozygous familial hypercholesterolemia.
Human immunodeficiency virus (HIV) infection
Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable)
Has hypertension: blood pressure > 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed
History of cardiac rhythm disturbances
Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death
Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry
History of malignancy, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
Has had major surgery within 1 month of screening
Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week)
Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening
History of allergy to bee sting
Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency
Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
Clinically significant history or presence of poorly controlled/uncontrolled systemic disease
Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk
History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)

Sites / Locations

Royal Prince Alfred Hospital
Concord Repatriation General Hospital, Gastroenterology & Liver Services
St. Vincent's Hospital Sydney
Westmead Hospital
Royal Adelaide Hospital
Monash Health Clayton Campus
St. Vincent's Hospital Melbourne
Royal Melbourne Hospital
Linear Clinical Research Ltd.
MHAT St. Pantaleimon OOD, Department of Gastroenterology
UMHAT St. Ivan Rilski EAD, Clinic of Gastroenterology
Diagnostic and Consultative Center - Focus 5 - Outpatient Medical Center, EOOD
Diagnostic and Consultative Center Mladost-M Varna
Queen Mary Hospital, Department of Medicine
Pusan National University Hospital
Inje University Busan Paik Hospital
Kyungpook National University Hospital
Seoul National University Hospital
Gangnam Severance Hospital, Yonsei University Health System
Severance Hospital, Yonsei University Health System
IMSP Spitalul Clinic de Boli Infectioase, Toma Ciorba
Middlemore Clinical Trials, Middlemore Hospital
Dunedin Hospital, Gastroenterology Research Unit
Auckland Clinical Studies
National Taiwan University Hospital, Yun-Lin Branch
Changhua Christian Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
King Chulalongkorn Memorial Hospital
Hospital of Tropical Diseases
Phramongkutklao Hospital, Division of Digestive and Liver Disease
Maharaj Nakhon Chiang Mai Hospital, Gastroenterology Division
Khon Kaen University
Thammasat University Hospital, Gastroenterology Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

Arm Description

Treatment-naïve, hepatitis B "e" antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous [IV]) every 4 weeks for 48 weeks (13 doses).

Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87.

Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.

Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.

Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.

Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87.

Treatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15.

Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline

The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment

The Principal Investigator (or medically qualified designee) will use clinical judgment to determine the relationship. An adverse event (AE) was considered "possibly related" when there is a reasonable possibility that the incident, experience, or outcome may have been caused by the product under investigation. An AE was considered "probably related" when there are facts, evidence, or arguments to suggest that the event is related to the product under investigation. Only AEs that occurred post-dose were considered treatment-emergent. Clinically significant abnormal laboratory findings or other abnormal assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs.

Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time

The qualitative HBsAg assay gives a binary result, positive or negative.

Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time

Time to HBsAg Loss

Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion

Percentage of Participants With Anti-HBs Seroconversion Over Time

Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time

Percentage of Participants With Resistance to ARC-520 Injection by Week 52

Resistance is defined as > 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test.

Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60

Resistance is defined as > 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test.

Percentage of Participants With HDV With Undetectable HDV Ribonucleic Acid (RNA) After 48 Weeks of Concomitant ARC-520 Injection and PEG IFN Alpha 2a Therapy Over Time (Cohort 7 Only)

Log Change From Baseline in Quantitative HBV Deoxyribonucleic Acid (DNA) Serum Levels Over Time

Full Information

NCT ID

NCT02577029

First Posted

October 14, 2015

Last Updated

January 11, 2019

Sponsor

Arrowhead Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02577029

Brief Title

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

Acronym

MONARCH

Official Title

A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

Company decision to discontinue trial

Study Start Date

December 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arrowhead Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.

Detailed Description

This is a multicenter, open-label study of ARC-520 based treatment regimens administered to patients with HBeAg positive or HBeAg negative immune active chronic Hepatitis B Virus (HBV) infection of various genotypes, or patients with Hepatitis D Virus (HDV). Eligible patients naive to previous treatment, and who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 alone or ARC-520 plus additional treatments such as entecavir (ETV) or tenofovir (TDF) and/or pegylated interferon alpha 2a (PEG IFN) therapy. The study may initially involve up to a total of 96 eligible chronic HBV and HDV infected patients. Patients in all cohorts will receive a total of 13 doses of ARC-520 at 2mg/kg or 4 mg/kg. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, adverse events assessment (AEs), 12-lead ECGs, liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, cytokines, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up. For each patient, the duration of the study is approximately 96 weeks, from enrolment to last visit. Prior to enrolment there is a 60 day screening period. Addition of new cohorts and additional treatment regimens are anticipated for this study.

6. Conditions and Keywords

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

Hepatitis B, Hepatitis D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

Arm Title

Cohort 6

Arm Type

Experimental

Arm Description

Arm Title

Cohort 7

Arm Type

Experimental

Arm Description

Arm Title

Cohort 8

Arm Type

Experimental

Arm Description

Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses).

Intervention Type

Drug

Intervention Name(s)

ARC-520

Intervention Description

ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline.

Intervention Type

Drug

Intervention Name(s)

entecavir

Other Intervention Name(s)

Baraclude

Intervention Description

0.5 mg once daily; oral

Intervention Type

Biological

Intervention Name(s)

pegylated interferon alpha 2a

Other Intervention Name(s)

Peginterferon, Pegasys

Intervention Description

180 mcg; subcutaneous injection once weekly

Intervention Type

Drug

Intervention Name(s)

tenofovir disoproxil

Other Intervention Name(s)

Viread

Intervention Description

300 mg once daily; oral

Intervention Type

Drug

Intervention Name(s)

antihistamine

Intervention Description

All participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline

Description

The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.

Time Frame

Baseline, Week 60

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment

Description

Time Frame

From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up

Title

Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time

Description

The qualitative HBsAg assay gives a binary result, positive or negative.

Time Frame

Weeks 52, 60, 72 and 96

Title

Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time

Time Frame

Weeks 52, 60, 72 and 96

Title

Time to HBsAg Loss

Time Frame

Baseline through Week 96

Title

Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion

Time Frame

Baseline through Week 96

Title

Percentage of Participants With Anti-HBs Seroconversion Over Time

Time Frame

Weeks 52, 60, 72 and 96

Title

Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time

Time Frame

Weeks 52, 60, 72 and 96

Title

Percentage of Participants With Resistance to ARC-520 Injection by Week 52

Description

Resistance is defined as > 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test.

Time Frame

Week 52

Title

Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60

Description

Resistance is defined as > 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test.

Time Frame

Baseline, Week 60

Title

Percentage of Participants With HDV With Undetectable HDV Ribonucleic Acid (RNA) After 48 Weeks of Concomitant ARC-520 Injection and PEG IFN Alpha 2a Therapy Over Time (Cohort 7 Only)

Time Frame

Weeks 52, 60, 72 and 96

Title

Log Change From Baseline in Quantitative HBV Deoxyribonucleic Acid (DNA) Serum Levels Over Time

Time Frame

Baseline, Weeks 52, 60, 72 and 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18 to 75 years of age Written informed consent No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment Diagnosis of HBeAg negative or positive chronic HBV infection. Must be HBsAg (+) during screening. Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1 Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) Exclusion Criteria: Pregnant or lactating Acute signs of hepatitis/other severe infections within 4 weeks of screening Use within the last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives History of poorly controlled autoimmune disease or any history of autoimmune hepatitis History of heterozygous or homozygous familial hypercholesterolemia. Human immunodeficiency virus (HIV) infection Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable) Has hypertension: blood pressure > 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed History of cardiac rhythm disturbances Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry History of malignancy, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer Has had major surgery within 1 month of screening Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week) Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening History of allergy to bee sting Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction Clinically significant history or presence of poorly controlled/uncontrolled systemic disease Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)

Facility Information:

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Concord Repatriation General Hospital, Gastroenterology & Liver Services

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

St. Vincent's Hospital Sydney

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Westmead Hospital

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Monash Health Clayton Campus

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

St. Vincent's Hospital Melbourne

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Linear Clinical Research Ltd.

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

MHAT St. Pantaleimon OOD, Department of Gastroenterology

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

UMHAT St. Ivan Rilski EAD, Clinic of Gastroenterology

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Diagnostic and Consultative Center - Focus 5 - Outpatient Medical Center, EOOD

City

Sofia

ZIP/Postal Code

1463

Country

Bulgaria

Facility Name

Diagnostic and Consultative Center Mladost-M Varna

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Facility Name

Queen Mary Hospital, Department of Medicine

City

Hong Kong

Country

China

Facility Name

Pusan National University Hospital

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Inje University Busan Paik Hospital

City

Busan

Country

Korea, Republic of

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

Gangnam Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

6273

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

Country

Korea, Republic of

Facility Name

IMSP Spitalul Clinic de Boli Infectioase, Toma Ciorba

City

Chisinau

ZIP/Postal Code

MD-2004

Country

Moldova, Republic of

Facility Name

Middlemore Clinical Trials, Middlemore Hospital

City

Papatoetoe

State/Province

Aukland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

Dunedin Hospital, Gastroenterology Research Unit

City

Dunedin

State/Province

Otago-Southland

Country

New Zealand

Facility Name

Auckland Clinical Studies

City

Auckland

ZIP/Postal Code

1010

Country

New Zealand

Facility Name

National Taiwan University Hospital, Yun-Lin Branch

City

Douliou

State/Province

Yunlin County

ZIP/Postal Code

640

Country

Taiwan

Facility Name

Changhua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

King Chulalongkorn Memorial Hospital

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Hospital of Tropical Diseases

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Phramongkutklao Hospital, Division of Digestive and Liver Disease

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Maharaj Nakhon Chiang Mai Hospital, Gastroenterology Division

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Khon Kaen University

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Thammasat University Hospital, Gastroenterology Unit

City

Pathumthani

ZIP/Postal Code

12120

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

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