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NCT Number: NCT00922207

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhua Christian Hospital; Internal Medicine, Changhua, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, 18-65 years of age;
  • HBeAg+ve for >=3 months;
  • positive serum HBV DNA within 3 months prior to entry;
  • patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
  • >=3 months treatment-free interval from nucleotide analogues.

Exclusion criteria

  • evidence of decompensated liver disease;
  • history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
  • co-infection with active hepatitis A,C or D, or HIV.

Treatment and study plan

Adefovir

Drug

From week -4 to week 2

Entecavir

Drug

From week -4 to week 2

Placebo

Drug

From week -4 to week 2

peginterferon alfa-2a [Pegasys]

Drug

180 micrograms sc weekly, from week 1-48

Primary outcomes

  1. Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment

    Time frame: Week 100

    HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).

Secondary outcomes

  1. Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

    Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

    HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.

  2. Percentage of Participants Who Were HBeAg Negative

    Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

  3. Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive

    Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

  4. Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels

    Time frame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100

    The normal range for ALT is 10 to 40 international units per liter (IU/L).

  5. Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

    Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

  6. Percentage of Participants With Combined Response

    Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

    Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2009
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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