'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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