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

NCT ID: NCT00487747

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-10-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon Alfa-2a

Group Type: EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 micrograms sc weekly for 48 weeks

Interventions

peginterferon alfa-2a [Pegasys]

180 micrograms sc weekly for 48 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Chelyabinsk, , Russia

Irkutsk, , Russia

Kazan', , Russia

Krasnoyarsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Novokuznetsk, , Russia

Novosibirsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Stavropol, , Russia

Tomsk, , Russia

Tyumen, , Russia

Ufa, , Russia

Volgograd, , Russia

Yakutsk, , Russia

Yekaterinburg, , Russia

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

ML20003

Identifier Type: -

Identifier Source: org_study_id