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Trial record 28 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Peg-interferon for Inactive Chronic Hepatitis B Carriers (INACTIVE)

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ClinicalTrials.gov Identifier: NCT02992704
Recruitment Status : Active, not recruiting
First Posted : December 14, 2016
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Seng Gee Lim, National University Health System, Singapore

Brief Summary:
Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended to be treated by guidelines as they are at low risk for complications. However, it is unclear if treatment can enhance HBsAg loss which has been shown to be associated with significantly lower risk of complications compared to those without HBsAg loss. Consequently, this is a proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B carriers in a randomised open label clinical trial comparing no treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on therapy and matched to an equivalent timepoint in the control arm. The sample size calculation is 30 patients in each arm for a 20% difference between any experimental arm and the control arm.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis, B Virus Carrier of Viral Hepatitis Type B Drug: Peginterferon Alfa-2A Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three arm, parallel open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Control Study for Inactive Chronic Hepatitis B Patients With Low Viral Load, With Peg-Interferon (INACTIVE)
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG 24 weeks
peginterferon alpha 2a 180mcg for 24 weeks
Drug: Peginterferon Alfa-2A
peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks
Other Name: pegasys

Experimental: PEG 48 weeks
peginterferon alpha 2a 180mcg 48 weeks
Drug: Peginterferon Alfa-2A
peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks
Other Name: pegasys

No Intervention: Control
No treatment for 72 weeks



Primary Outcome Measures :
  1. HBsAg loss [ Time Frame: 24 weeks after end of therapy ]
    Qualitative HBsAg assay reads "non-detectable"


Secondary Outcome Measures :
  1. HBsAg loss [ Time Frame: At the end of 24 and 48 weeks of peginterferon therapy ]
    Qualitative HBsAg assay reads "non-detectable"

  2. Decline in quantitative HBsAg level [ Time Frame: At week 24, 48 and 24 weeks after completion of therapy ]
    Based on quantitative HBsAg assay

  3. proportion of patients with undetectable HBV DNA [ Time Frame: At week 24, 48 of therapy, and 24 weeks after end of therapy ]
    HBV DNA assay<13.5 IU/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment naïve
  • Documented HBsAg or HBV DNA positive for ≥ 6 months.
  • Documented HBeAg negative and anti-HBe positive
  • ALT ≤1xULN
  • quantitative HBsAg <1,000 IU/ml
  • HBV DNA <2x104 IU/mL at screening
  • Absence of cirrhosis documented by liver biopsy or transient elastography within 6 months (Fibroscan®; Fibrosis stage >2 (score ≥ 10Kpa) will not be eligible for this study.)
  • Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
  • Patient is able to give written consent prior to study start and to comply with the study requirements.
  • Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken within 14 days of starting therapy

Exclusion Criteria:

  • Patients who are currently on treatment with nucleoside/nucleotide analogues or have been treated for Hepatitis B in the past
  • Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥ 10kpa)
  • Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.
  • Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin >1.2x upper limit of normal (ULN), prothrombin time (PT) >1.5xULN , serum bilirubin <35g/L, or prior history of clinical hepatic decompensation as illustrated by presence of (eg. ascites, encephalopathy, variceal haemorrhage)
  • Evidence of hepatocellular carcinoma
  • Absolute neutrophil count <1.5x10^9/L or Hemoglobin <12 g/L for men or <11 g/L for women, or platelet count < 90x10^9/L
  • History of depression or psychiatric disease
  • Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) >1.2 ULN or 0.8xLLN or thyroid dysfunction
  • Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6 months before trial entry
  • Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
  • Malignant disease within 5 years of trial entry
  • Women who are pregnant and who are not practicing adequate birth control measures, (defined as two methods of birth control with at least one barrier method) or who are lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992704


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119228
Sponsors and Collaborators
Seng Gee Lim
Roche Pharma AG
Investigators
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Principal Investigator: Seng Gee Lim, MBBS, FRACP, FRCP, MD National University Health System

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Responsible Party: Seng Gee Lim, Director of Hepatology, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT02992704     History of Changes
Other Study ID Numbers: 2014/00205
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs