Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 18, 2007
Last updated: February 21, 2017
Last verified: February 2017
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL [ Time Frame: Week 96 ]
    This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.

  • Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL [ Time Frame: Week 96 ]
    This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.

Secondary Outcome Measures:
  • Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion [ Time Frame: Week 96 ]
    Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.

  • Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT [ Time Frame: Week 96 ]
    Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.

  • Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ]
    All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.

  • Mean Change in Laboratory Parameters (ALT Levels) [ Time Frame: From Screening (Day 0) to Week 96 ]
    Mean Change in Laboratory parameters (ALT levels) is reported.

Enrollment: 18
Study Start Date: August 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginterferon Alfa-2a Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • chronic hepatitis B;
  • Hepatitis B Virus (HBV) DNA >100,000 copies/mL.

Exclusion Criteria:

  • previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
  • evidence of decompensated liver disease;
  • history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
  • coinfection with hepatitis A, C or D, or HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00487747

Russian Federation
Chelyabinsk, Russian Federation, 454052
Ekaterinburg, Russian Federation, 620020
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664047
Kazan, Russian Federation, 420097
Krasnoyarsk, Russian Federation, 660049
Moscow, Russian Federation, 111020
Moscow, Russian Federation, 115516
Moscow, Russian Federation, 121293
Moscow, Russian Federation, 123367
Moscow, Russian Federation
Nizhny Novgorod, Russian Federation, 603022
Novokuznetsk, Russian Federation, 654063
Novosibirsk, Russian Federation, 630016
Rostov-na-donu, Russian Federation, 344010
Samara, Russian Federation, 443021
St Petersburg, Russian Federation, 190103
Stavropol, Russian Federation, 355017
Tomsk, Russian Federation, 634050
Tumen, Russian Federation, 625002
UFA, Russian Federation, 450000
Volgograd, Russian Federation, 400138
Yakutsk, Russian Federation, 677000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00487747     History of Changes
Other Study ID Numbers: ML20003
Study First Received: June 18, 2007
Results First Received: November 2, 2016
Last Updated: February 21, 2017

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 23, 2017