Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 159 of 362 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Ionis Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02981602
First received: December 1, 2016
Last updated: May 9, 2017
Last verified: May 2017
  Purpose
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection

Condition Intervention Phase
Chronic Hepatitis B Atypical
Drug: IONIS-HBVRx
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients With Chronic HBV Infection

Resource links provided by NLM:


Further study details as provided by Ionis Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of multiple doses of IONIS-HBVRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters) [ Time Frame: 26 Weeks ]
    The safety and tolerability of IONIS-HBVRx will be assessed by determining the incidence, severity, and dose relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with ISIS 505358 will be compared with those from subjects dosed with placebo.


Secondary Outcome Measures:
  • Plasma HBV DNA Concentration [ Time Frame: Day 29 ]
    IONIS-HBVRx will be compared with those from subjects dosed with placebo.


Estimated Enrollment: 24
Actual Study Start Date: February 22, 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IONIS-HBVRx
Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection
Drug: IONIS-HBVRx
Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection
Other Name: ISIS 505358
Placebo Comparator: Placebo
Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
Drug: Placebo
Placebo

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Serum HBsAg ≥ 50 IU/mL

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
  • 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])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02981602

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Vincent Lopez    910 558 2051    Vincent.Lopez@ppdi.com   
Contact    910 558 2051      
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Investigators
Study Director: Vincent Lopez PPD
  More Information

Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02981602     History of Changes
Other Study ID Numbers: ISIS 505358-CS3
Study First Received: December 1, 2016
Last Updated: May 9, 2017

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

Keywords provided by Ionis Pharmaceuticals, Inc.:
Hepatitis
Chronic
HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 25, 2017