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

HBV Clinical Trial

Official title:

To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02454764
• Other study ID #: ILBS-HBV-001
• Status: Withdrawn
• Phase: N/A
• First received: May 22, 2015
• Last updated: February 7, 2018

Study information

• Verified date: July 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV

Intervention

Drug:
• Tenofovir + Interferon alpha 2b

• Tenofovir disoproxil Fumarate

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart		65 weeks
Secondary	HBsAg loss		64 weeks
Secondary	Absence of quantifiable serum HBV DNA		64 weeks
Secondary	Development of serious adverse effects, acute hepatitis or hepatic decompensation		64 weeks