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Study of Safety and Tolerability of DCR HBVS | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of Safety and Tolerability of DCR HBVS

A Three-Part, Phase 1, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DCR-HBVS in Healthy Volunteers and Patients With Chronic Hepatitis B

NCT03772249•Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

View on ClinicalTrials.gov

Summary

DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.

Detailed Description

DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy at the time of screening as determined by medical evaluation.
•Capable of giving informed consent.
•12-lead ECG within normal limits or with no clinically significant abnormalities.
•Negative screen for alcohol or drugs of abuse.
•Non-smokers for at least 3 months with a negative urinary cotinine concentration at screening.
•BMI within range 18.0 - 32.0 kg/m2 (inclusive).
•Female participants not pregnant, not breastfeeding, and not of childbearing potential or willing to follow contraceptive guidance.
•Chronic hepatitis B infection (Group B and C only).
•Clinical history compatible with compensated liver disease with no evidence of cirrhosis (Group B and C only).
•Continuously on nucleotides (NUC) therapy for at least 12 weeks prior to screening (Group C only).

Exclusion Criteria

•History of any medical condition that may interfere with the absorption, distribution, or elimination of study drug.
•Poorly controlled or unstable hypertension.
•History of diabetes mellitus treated with insulin or hypoglycemic agents.
•History of asthma requiring hospital admission within the preceding 12 months.
•Evidence of G-6-PD deficiency.
•Currently poorly controlled endocrine conditions, excluding thyroid conditions.
•History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
•Clinically relevant surgical history.
•Use of prescription medications (excluding contraception for women) within 4 weeks prior to the administration of study intervention.
•Use of clinically relevant over-the-counter medication or supplements (excluding routine vitamins) within 7 days of first dosing.
+3 more criteria

Locations (9)

Monash Health

Clayton, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Queen Mary Hospital (The University of Hong Kong)

Hong Kong, Hong Kong

Clinical Site

Auckland, New Zealand

Middlemore Hospital

Auckland, New Zealand

Seoul National University Hospital

Seoul, South Korea

Seoul Metropolitan Government - Seoul National University Boramae Medical Center

Soeul, South Korea

King Culalongkorn Memorial Hospital

Bangkok, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Key Dates

Start Date

December 28, 2018

Primary Completion Date

July 12, 2022

Completion Date

July 12, 2022

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Hepatitis B, Chronic

Interventions

DCR-HBVS

DRUG

Placebo for DCR-HBVS

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Safety and Tolerability of DCR HBVS

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels