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

NCT01589952 | Unknown Phase 1

• 1 other identifier: BB1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B

Keywords

Pegalyted interferon; Entecavir

Outcome Measures

Primary Outcomes (1)

• Combination of half dose and reduced duration pegalyted interferon in combination with entecavir achieves biochemical and virologic response in chronic hepatitis B

  Combination of half dose and reduced duration pegalyted interferon in combination with entecavir achieves biochemical and virologic response in chronic hepatitis B

  6 months

Study Arms (1)

Pegylated Interferon, Entecavir

EXPERIMENTAL

'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

Interventions

Pegalyted interferon, Entecavir DRUG

Pegalyted interferon: 90 micro gms subcutaneously once weekly for 24 weeks Entecavir: 0.5 mg orally once daily for 24 weeks

Also known as: Pegasys, Pegin, Optipeg, Baraclude, Enviral, Teviral, Barcavir, Tecavir

Pegylated Interferon, Entecavir

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Coinfection with HCV or HIV, cirrhosis of liver

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mamun A Mahtab, MSc MD FACG

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Hepatology

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 2, 2012

Record last verified: 2012-05

Locations

BA (1)