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

NCT00487747 | Completed Phase 4 Results

• 1 other identifier: ML20003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 23

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion

  Week 96

• Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT

  Week 96

• Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

  Up to Week 96

• Mean Change in Laboratory Parameters (ALT Levels)

  From Screening (Day 0) to Week 96

Study Arms (1)

Peginterferon Alfa-2a

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180 micrograms sc weekly for 48 weeks

Peginterferon Alfa-2a

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (23)

Unknown Facility

Chelyabinsk, 454052, Russia

Location

Unknown Facility

Irkutsk, 664047, Russia

Location

Unknown Facility

Kazan', 420097, Russia

Location

Unknown Facility

Krasnoyarsk, 660049, Russia

Location

Unknown Facility

Moscow, 111020, Russia

Location

Unknown Facility

Moscow, 115516, Russia

Location

Unknown Facility

Moscow, 121293, Russia

Location

Unknown Facility

Moscow, 123367, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Nizhny Novgorod, 603022, Russia

Location

Unknown Facility

Novokuznetsk, 654063, Russia

Location

Unknown Facility

Novosibirsk, 630016, Russia

Location

Unknown Facility

Rostov-on-Don, 344010, Russia

Location

Unknown Facility

Saint Petersburg, 190103, Russia

Location

Unknown Facility

Samara, 443021, Russia

Location

Unknown Facility

Stavropol, 355017, Russia

Location

Unknown Facility

Tomsk, 634050, Russia

Location

Unknown Facility

Tyumen, 625002, Russia

Location

Unknown Facility

Ufa, 450000, Russia

Location

Unknown Facility

Volgograd, 400138, Russia

Location

Unknown Facility

Yakutsk, 677000, Russia

Location

Unknown Facility

Yekaterinburg, 620020, Russia

Location

Unknown Facility

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: August 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-02

Locations

RU (23)