Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B. (NCT NCT00487747)
NCT ID: NCT00487747
Last Updated: 2017-04-06
Results Overview
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.
COMPLETED
PHASE4
18 participants
Week 96
2017-04-06
Participant Flow
The study was conducted at 7 centers in Russia.
Out of 20 participants, 18 were included in the study. (4 were Hepatitis B Early Antigen \[HBeAg\] positive and 14 were HBeAg-negative).
Participant milestones
| Measure |
Peginterferon Alfa-2a
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.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a
n=18 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Hepatitis B Early Antigen (HBeAg) positive participants
|
4 participants
n=5 Participants
|
|
HBeAg-negative participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 96Population: All participants who received at least one dose of the study drug were considered for analysis.
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.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=4 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
|
4 Participants
|
PRIMARY outcome
Timeframe: Week 96Population: All participants who received at least one dose of the study drug were considered for analysis.
This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=14 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: All participants who received at least one dose of the study drug were considered for analysis.
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.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=4 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
HBV DNA <400 copies/mL
|
4 Participants
|
|
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
HBsAg seroconversion
|
0 Participants
|
|
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
ALT normalization
|
4 Participants
|
|
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
Sustained HBe seroconversion
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: All participants who received at least one dose of the study drug were considered for analysis.
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.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=14 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
HBV DNA <400 copies/mL
|
3 Participants
|
|
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
HBsAg seroconversion
|
2 Participants
|
|
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
ALT normalization
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Safety population included all participants who received at least one dose of the study drug.
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.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=18 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Any AEs
|
3 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: From Screening (Day 0) to Week 96Population: Safety population included all participants who received at least one dose of the study drug.
Mean Change in Laboratory parameters (ALT levels) is reported.
Outcome measures
| Measure |
Peginterferon Alfa-2a
n=18 Participants
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 1)
|
92.9 International units per liter (IU/L)
Standard Deviation 73.2
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 2)
|
97.2 International units per liter (IU/L)
Standard Deviation 89.9
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 4)
|
109.4 International units per liter (IU/L)
Standard Deviation 133.6
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 8)
|
81.2 International units per liter (IU/L)
Standard Deviation 105.4
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT Week 12)
|
65.1 International units per liter (IU/L)
Standard Deviation 35.9
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 18)
|
53.3 International units per liter (IU/L)
Standard Deviation 26.2
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 24)
|
66.2 International units per liter (IU/L)
Standard Deviation 32.3
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 32)
|
55 International units per liter (IU/L)
Standard Deviation 30.2
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 40)
|
46 International units per liter (IU/L)
Standard Deviation 17.6
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 48)
|
38.4 International units per liter (IU/L)
Standard Deviation 18.4
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 52)
|
37.1 International units per liter (IU/L)
Standard Deviation 5.1
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 60)
|
40.5 International units per liter (IU/L)
Standard Deviation 15.1
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 72)
|
36.9 International units per liter (IU/L)
Standard Deviation 4.5
|
|
Mean Change in Laboratory Parameters (ALT Levels)
ALT (Week 96)
|
32.8 International units per liter (IU/L)
Standard Deviation 8.1
|
Adverse Events
Peginterferon Alfa-2a
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peginterferon Alfa-2a
n=18 participants at risk
Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
2/18 • Up to Week 96
Safety population included all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Up to Week 96
Safety population included all participants who received at least one dose of the study drug.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER