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

PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: peginterferon alfa-2a [Pegasys]

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• 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
  • Moscow, Russian Federation, 111020
  • Moscow, Russian Federation, 115516
  • Moscow, Russian Federation, 121293
  • Moscow, Russian Federation, 123367
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peginterferon Alfa-2a	Drug: peginterferon alfa-2a [Pegasys]; 180 micrograms sc weekly for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL	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.	Week 96
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL	This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.	Week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion	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.	Week 96
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT	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.	Week 96
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)	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.	Up to Week 96
Mean Change in Laboratory Parameters (ALT Levels)	Mean Change in Laboratory parameters (ALT levels) is reported.	From Screening (Day 0) to Week 96

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 18, 2007
• First Submitted That Met QC Criteria: June 18, 2007
• First Posted (Estimate): June 19, 2007

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2a
• Other Study ID Numbers: ML20003