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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00487747
Recruitment Status : Completed
First Posted : June 19, 2007
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: peginterferon alfa-2a [Pegasys] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Study Start Date : August 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Peginterferon Alfa-2a Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487747


Locations
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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
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00487747    
Other Study ID Numbers: ML20003
First Posted: June 19, 2007    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents