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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Intervention Drug: peginterferon alfa-2a [Pegasys]
Enrollment 18
Recruitment Details The study was conducted at 7 centers in Russia.
Pre-assignment Details Out of 20 participants, 18 were included in the study. (4 were Hepatitis B Early Antigen [HBeAg] positive and 14 were HBeAg-negative).
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Period Title: Overall Study
Started 18
Completed 7
Not Completed 11
Reason Not Completed
Adverse Event             1
Lost to Follow-up             9
Lack of Efficacy             1
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All participants who received at least one dose of the study drug were included.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
4
  22.2%
Male
14
  77.8%
Hepatitis B Early Antigen (HBeAg) positive participants  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
4
HBeAg-negative participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
14
  77.8%
1.Primary Outcome
Title Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
Hide Description 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.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were considered for analysis.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
4
2.Primary Outcome
Title Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
Hide Description This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were considered for analysis.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
3
3.Secondary Outcome
Title Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
Hide Description 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.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were considered for analysis.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
HBV DNA <400 copies/mL 4
HBsAg seroconversion 0
ALT normalization 4
Sustained HBe seroconversion 4
4.Secondary Outcome
Title Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
Hide Description 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.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were considered for analysis.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
HBV DNA <400 copies/mL 3
HBsAg seroconversion 2
ALT normalization 3
5.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of the study drug.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
Any AEs 3
Any SAEs 0
6.Secondary Outcome
Title Mean Change in Laboratory Parameters (ALT Levels)
Hide Description Mean Change in Laboratory parameters (ALT levels) is reported.
Time Frame From Screening (Day 0) to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of the study drug.
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALT (Week 1) 92.9  (73.2)
ALT (Week 2) 97.2  (89.9)
ALT (Week 4) 109.4  (133.6)
ALT (Week 8) 81.2  (105.4)
ALT Week 12) 65.1  (35.9)
ALT (Week 18) 53.3  (26.2)
ALT (Week 24) 66.2  (32.3)
ALT (Week 32) 55  (30.2)
ALT (Week 40) 46  (17.6)
ALT (Week 48) 38.4  (18.4)
ALT (Week 52) 37.1  (5.1)
ALT (Week 60) 40.5  (15.1)
ALT (Week 72) 36.9  (4.5)
ALT (Week 96) 32.8  (8.1)
Time Frame Up to Week 96
Adverse Event Reporting Description Safety population included all participants who received at least one dose of the study drug.
 
Arm/Group Title Peginterferon Alfa-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
All-Cause Mortality
Peginterferon Alfa-2a
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Peginterferon Alfa-2a
Affected / at Risk (%)
Total   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon Alfa-2a
Affected / at Risk (%)
Total   3/18 (16.67%) 
Blood and lymphatic system disorders   
Neutropenia  1  2/18 (11.11%) 
Psychiatric disorders   
Depression  1  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00487747    
Other Study ID Numbers: ML20003
First Submitted: June 18, 2007
First Posted: June 19, 2007
Results First Submitted: November 2, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017