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Your journey
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More info
You can access this
clinical trial
if you have
Chronic Hepatitis B
and you are
between 20 and 65
years old
1
2
This is a medium phase trial determining
the safety and dosage of the new treatment, as well as its efficacy.
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The purpose

According to published literature, treatment with pegylated interferon (Peg-IFN) is associated with end of treatment response in treatment naive patients with chronic hepatitis B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN results in improvement of liver histology and down regulation of progression to cirrhosis of liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is that only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral drug, entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes improvement of liver histology in only 30%, possibly because of its lack of immune modulatory ability like Peg-IFN. Also, ETV treatment is associated with several complications like emergence of HBV mutant. The aim of this study is to assess whether the combination of these two 'unique' anti-viral drugs offer the best possible outcome to treatment-naïve CHB patients, in terms of treatment response (virological and biochemical), treatment cost and duration and adverse events.

Provided treatments

  • Drug: Pegalyted interferon, Entecavir

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01589952. The sponsor of the trial is Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh and it is looking for 20 volunteers for the current phase.
Official trial title:
Pilot Study of First Line Combination Treatment With Low Dose Pegylated Interferon and Entecavir in Treatment-naïve Patients With Chronic Hepatitis B.