The Evaluation of efficacy and safety of Tenofovir in combination with peginterferon alpha-2a subcutaneous for 48 weeks in patients with chronic hepatitis B viral infections (HBV)

Phase 4

Recruiting

• Conditions: Chronic Hepatitis B viral infection; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12610001101077
• Lead Sponsor: Dr Anouk Dev

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Documented Chronic Hepatitis B defined by all of the following:
1.Clinical history compatible with CHB
2.Detectable serum HBsAg at the Screening visit and at least 6 months prior
3.HBeAg-positive and HBeAb-negative at the Screening visit
4.History of evidence of chronic liver inflammation, documented by previous history of elevated serum ALT (at least two documented elevated ALT values spanning six months or more))
5.Elevated serum ALT level (1.1 – 10 x upper limit of normal (ULN)) at the Screening visit
6.Serum HBV DNA level = 3 log10 IU/mL at the screening visit
7.Chronic liver inflammation on a liver biopsy performed within the previous 5 years

Exclusion Criteria

1.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
2.Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
3.Has had any of the following drug therapy:
*Received nucleoside or nucleotide therapy whether approved or investigational in the three months before screening for this study.
*Received conventional interferon alpha or other immunomodulatory therapies in the six months before screening for this study.
*Has previously received Pegylated Interferon alpha at any stage for the treatment of CHB
4.Has a medical condition that requires frequent or prolonged use of systemic corticosteroids although inhaled or intra-articular corticosteroids are allowed.
5.Has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
6.Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to demonstrate the efficacy of the combination of peginterferon alpha-2a with Tenofovir in achieving sustained HBV suppression as measured by HBsAg loss in adult patients with HBeAg positive CHB by serum assay (blood test)[24weeks post dosing of study medication.]

Secondary Outcome Measures

Name	Time	Method
Evaluating the effect of the combination of peginterferon alpha-2a with Tenofovir on HBsAg clearance rates by a lead in phase of Peginterferon monotherapy for 24 weeks prior to combination therapy by serum assay (blood test)[24weeks post dosing of study medication.];Evaluating the effect of peginterferon and Tenofovir combination therapy on other parameters of viral suppression including; HBV DNA non-detectability, reduction from baseline, and sustained reduction in HBV DNA over the course of the study. HBeAg loss, HBeAb seroconversion and reduction in HBeAg titres from baseline HBsAg loss, HBsAb seroconversion and reduction in HBsAg titres from baseline and ALT normalization by serum assay (blood test)[24weeks post dosing of study medication.]