CompletedPhase 2

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

Hong Kong, South Korea31 participantsStarted 2017-02-24

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Liver biopsy (i.e., Metavir Score F4) within 2 years of Screening, or
✕. Fibroscan \> 12 KPa, within 12 months of Screening, or
✕. 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

What they're measuring

Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%)

Timeframe: Up to Day 211

Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time

Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211

Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time

Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211

Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate

Timeframe: Outcome Measure Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211

Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine

Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211

Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets

Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211

Trial details

NCT IDNCT02981602

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-18

Results submitted2020-11-23

View on ClinicalTrials.gov More Hepatitis B trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Liver biopsy (i.e., Metavir Score F4) within 2 years of Screening, or
✕. Fibroscan \> 12 KPa, within 12 months of Screening, or
✕. 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