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

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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

Tracking Information
First Submitted Date  ICMJE June 18, 2007
First Posted Date  ICMJE June 19, 2007
Results First Submitted Date  ICMJE November 2, 2016
Results First Posted Date  ICMJE April 6, 2017
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2007)
HBeAg positive patients: HBV DNA <100,000 copies/mL at end of follow-up. HBeAg negative patients: HBV DNA <20,000 copies/mL at end of follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2007)
Efficacy: HBV DNA <400 copies/mL; HBsAg seroconversion; ALT normalisation; sustained HBe seroconversion in HBeAg positive patients. Safety: AEs, lab parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Official Title  ICMJE PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Study Arms  ICMJE Experimental: Peginterferon Alfa-2a
Intervention: Drug: peginterferon alfa-2a [Pegasys]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2017)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00487747
Other Study ID Numbers  ICMJE ML20003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP