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Pegylated Interferon and Entecavir Combination in Chronic Hepatitis B (CHB) (Bangabandhu)

This study is currently recruiting participants.
Verified May 2012 by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor:
Information provided by (Responsible Party):
Dr. Mamun-Al-Mahtab, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01589952
First received: May 1, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: Pegalyted interferon, Entecavir
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of First Line Combination Treatment With Low Dose Pegylated Interferon and Entecavir in Treatment-naïve Patients With Chronic Hepatitis B.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Combination of half dose and reduced duration pegalyted interferon in combination with entecavir achieves biochemical and virologic response in chronic hepatitis B [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Combination of half dose and reduced duration pegalyted interferon in combination with entecavir achieves biochemical and virologic response in chronic hepatitis B


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated Interferon, Entecavir
'Pegylated Interferon, Entecavir' arm will consist of 20 chronic hepatitis B patients who will receive Pegylated Interferon 90 micro gms subcutaneously once weekly in combination with entecavir 0.5 mg orally once daily for 24 weeks
 Drug: Pegalyted interferon, Entecavir
Pegalyted interferon: 90 micro gms subcutaneously once weekly for 24 weeks Entecavir: 0.5 mg orally once daily for 24 weeks
Other Names:
  • Pegasys
  • Pegin
  • Optipeg
  • Baraclude
  • Enviral
  • Teviral
  • Barcavir
  • Tecavir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HBsAg positive >6 months, HBeAg positive or negative, serum ALT normal or raised and HBV DNA >1000 copies/ml in HBeAg negative or HBV DNA >10000 copies/ml in HBeAg positive.

Exclusion Criteria:

  • Coinfection with HCV or HIV, cirrhosis of liver
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589952

Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh, 1000
Contact: Mamun A Mahtab, MSc, MD, FACG     +8801711567275     shwapnil@agni.com    
Contact: Helal Uddin, BSc, DPH     +8801819251514     bhc@dhaka.net    
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
Principal Investigator: Mamun A Mahtab, MSc MD FACG Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

No publications provided

Responsible Party: Dr. Mamun-Al-Mahtab, Associate Professor of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01589952     History of Changes
Other Study ID Numbers: BB1
Study First Received: May 1, 2012
Last Updated: May 1, 2012
Health Authority: Bangladesh: Directorate of Drug Administration

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Pegalyted interferon
Entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Entecavir
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013