A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
|ClinicalTrials.gov Identifier: NCT00487747|
Recruitment Status : Completed
First Posted : June 19, 2007
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: peginterferon alfa-2a [Pegasys]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B|
|Study Start Date :||August 2006|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
|Experimental: Peginterferon Alfa-2a||
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487747
|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, 111020|
|Moscow, Russian Federation, 115516|
|Moscow, Russian Federation, 121293|
|Moscow, Russian Federation, 123367|
|Moscow, Russian Federation|
|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|
|Study Director:||Clinical Trials||Hoffmann-La Roche|