'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT

NCT02454764 | Withdrawn

• 1 other identifier: ILBS-HBV-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT \>/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response

Conditions

HBV

Outcome Measures

Primary Outcomes (1)

• Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart

  65 weeks

Secondary Outcomes (3)

• HBsAg loss

  64 weeks

• Absence of quantifiable serum HBV DNA

  64 weeks

• Development of serious adverse effects, acute hepatitis or hepatic decompensation

  64 weeks

Study Arms (2)

Tenofovir + Interferon alpha 2 b

EXPERIMENTAL

Drug: Tenofovir disoproxil Fumarate

Tenofovir

ACTIVE COMPARATOR

Drug: Tenofovir + Interferon alpha 2b

Interventions

Tenofovir + Interferon alpha 2b DRUG

Tenofovir

Tenofovir disoproxil Fumarate DRUG

Tenofovir + Interferon alpha 2 b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months,
• HBeAg (+),
• ALT \< ULN (Upper Limit Normal) on 2 or more occasions in last 6 months \[ULN: 45\]
• HBV DNA \>2000 IU/mL
• Age \> 18 years

You may not qualify if:

• Decompensated Cirrhosis
• Severe HBV flare with reactivation
• Presentation as ACLF (Acute on Chronic liver Failure)
• Baseline ALT \> ULN (Upper Limit Normal)
• Contraindications to PEG-IFN therapy
• Prior HBV antiviral therapy within 6 months of enrollment
• Co-infections with HCV/HIV
• ANA +(autoantibodies suggestive of autoimmune disease) \>1:80
• Patient not willing for enrollment in the study
• Pregnancy, lactation
• Patients who leave the study/ discontinue the therapy before completion

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Tenofovir; Interferon alpha-2

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 27, 2015
• Primary Completion: January 1, 2018
• Last Updated: February 8, 2018

Record last verified: 2016-07

Locations

IN (1)