A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
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|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|
|Actual Primary Completion Date :||October 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|