DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Clinical Details

Official title: A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment

Secondary outcome:

Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72

Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment

Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment

Percentage of Participants With Normal Alanine Aminotransferase (ALT)

Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment

Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment

Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment

Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment

Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment

Quantitative HBV-DNA 24 Weeks Following End of Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA

>500,000 copies/mL, and anti-HBs negative;

- liver disease consistent with Chronic Hepatitis B.

Exclusion Criteria:

- antiviral therapy for CHB within previous 6 months;

- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus

(HDV) or Human immuno deficiency virus (HIV);

- evidence of decompensated liver disease;

- medical condition associated with chronic liver disease.

Locations and Contacts

Fitzroy 3065, Australia

Greenslopes 4120, Australia

Woolloongabba 4102, Australia

Campinas 13081-970, Brazil

Ribeirão Preto 14049-900, Brazil

Salvador 40150-130, Brazil

Santo Andre 09060-650, Brazil

Sao Paulo 05403-000, Brazil

Beijing 100050, China

Beijing 100054, China

Guangzhou 510630, China

Hunan 410008, China

Shanghai 201508, China

Shanghai 200025, China

Clichy 92118, France

Montpellier 34295, France

Nice 06202, France

Strasbourg 67091, France

Toulouse 31078, France

Villejuif 94804, France

Berlin 13353, Germany

Frankfurt Am Main 60590, Germany

Freiburg 79106, Germany

Hannover 30625, Germany

Köln 50937, Germany

Hong Kong 852, Hong Kong

Hong Kong, Hong Kong

Seoul 110-744, Korea, Republic of

Seoul 120-752, Korea, Republic of

Seoul 138-736, Korea, Republic of

Auckland 100, New Zealand

Hamilton, New Zealand

Samara 443021, Russian Federation

Smolensk 214006, Russian Federation

St Petersburg 190103, Russian Federation

Stavropol 355017, Russian Federation

Singapore 169608, Singapore

Kaohsiung 807, Taiwan

Taipei 100, Taiwan

Taoyuan 333, Taiwan

Bangkok 10400, Thailand

Bangkok 10700, Thailand

Chiang Mai 50202, Thailand

Khon Kaen 40002, Thailand

Songkhla 90112, Thailand

Los Angeles, California 90095, United States

Palo Alto, California 94304-1509, United States

San Diego, California 92105, United States

San Francisco, California 94115, United States

San Jose, California 95116, United States

Atlanta, Georgia 30306, United States

Flushing, New York 11355, United States

Portland, Oregon 97227, United States

Philadelphia, Pennsylvania 19141, United States

Richmond, Virginia 23249, United States

Additional Information

Starting date: March 2007
Last updated: June 19, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017