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

NCT ID: NCT02454764

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenofovir + Interferon alpha 2 b

Group Type: EXPERIMENTAL

Tenofovir disoproxil Fumarate

Intervention Type: DRUG

Tenofovir

Group Type: ACTIVE_COMPARATOR

Tenofovir + Interferon alpha 2b

Intervention Type: DRUG

Interventions

Tenofovir + Interferon alpha 2b

Intervention Type: DRUG

Tenofovir disoproxil Fumarate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-HBV-001

Identifier Type: -

Identifier Source: org_study_id