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

Not Applicable

Withdrawn

• Conditions: HBV
• Interventions: Drug: Tenofovir + Interferon alpha 2b; Drug: Tenofovir disoproxil Fumarate

• Registration Number: NCT02454764
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Status Verified: 2016-07
• Primary Completion: 2018-01-01
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir	Tenofovir + Interferon alpha 2b	-
Tenofovir + Interferon alpha 2 b	Tenofovir disoproxil Fumarate	-

Primary Outcome Measures

Name	Time	Method
Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart	65 weeks

Secondary Outcome Measures

Name	Time	Method
HBsAg loss	64 weeks
Absence of quantifiable serum HBV DNA	64 weeks
Development of serious adverse effects, acute hepatitis or hepatic decompensation	64 weeks

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India