Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2019-12-26

Brief Summary

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To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection

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Detailed Description

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This study examines the effects of IONIS-HBVRx or placebo (3:1 randomization) administered subcutaneously to treatment-naïve patients who are chronically infected with HBV and the effects of subsequent nucleos(t)ide analogue treatment on these patients.

Conditions

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Hepatitis B Chronic Hepatitis B Atypical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IONIS-HBVRx

Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection

Group Type EXPERIMENTAL

IONIS-HBVRx

Intervention Type DRUG

Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection

Placebo

Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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IONIS-HBVRx

Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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ISIS 505358

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 70 years
* Chronic HBV infection ≥6 months (e.g., positive for serum HBsAg ≥ 6 months)
* Plasma HBV DNA ≥ 2 x 1000 IU/mL (HBV DNA adequately suppressed for exploratory nucleos(t)ide analogue experienced cohort)
* Serum HBsAg ≥ 50 IU/mL
* Exploratory nucleos(t)ide analogue experienced cohort only: currently taking and have been taking tenofovir or entecavir without changes in drug, dose level and/or frequency of administration for ≥ 12 months and expect to continue taking without change through to the end of their participation in this study

Exclusion Criteria

* Current or prior receipt of anti-HBV nucleos(t)ide analogue therapy. Patients who have failed prior interferon treatment, greater than 6 months prior to Screening, may be evaluated for possible participation in the study (not applicable for exploratory nucleos(t)ide analogue experienced cohort)
* History of liver cirrhosis and/or evidence of cirrhosis as determined by any of the following:

1. Liver biopsy (i.e., Metavir Score F4) within 2 years of Screening, or
2. Fibroscan \> 12 KPa, within 12 months of Screening, or
3. AST-to-Platelet Index (APRI) \> 2 and Fibrosure result \> 0.7 within 12 months of Screening For patients without a test for cirrhosis in the above timeframes, Fibroscan, or APRI and Fibrosure, may be performed during the screening period to rule out cirrhosis
* History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices
* History of liver disease other than Hepatitis B
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
* BMI \> 35 kg/m2
* History of, or suspected presence of vasculitis
* Received solid organ or bone marrow transplant
* Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone)
* Diagnosed hepatocellular carcinoma or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein ≥ 200 ng/mL. If the screening alpha-fetoprotein is ≥ 50 ng/mL and \< 200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization
* Clinically-significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination
* History of bleeding diathesis or coagulopathy
* History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa)
* History of excess alcohol consumption within 6 months of Screening
* History of drug abuse or dependence, or recreational use of drugs: within 3 months of Screening for soft drugs (such as marijuana) and within 1-year of Screening for hard drugs (such as cocaine, phencyclidine \[PCP\])

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No