Hepatitis B, Chronic
Conditions
Brief summary
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.
Interventions
DRUGPeginterferon alfa-2a
180 mcg subcutaneously once per week for 48 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult participants, 18-70 years of age; * HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months; * anti-HBs negative; * Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
Exclusion criteria
* Previous antiviral or interferon-based therapy for chronic hepatitis B; * Evidence of decompensated liver disease; * Chronic liver disease other than viral hepatitis; * Co-infection with active hepatitis A, C or D virus; * Co-infection with human immunodeficiency virus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) | Week 72 | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline. |
| Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL | Week 72 | HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Anti-HBs Positive Participants | Week 48 and Week 72 | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported. |
| Mean Alanine Aminotransferase (ALT) Concentrations | Week 48 and Week 72 | — |
| Number of Participants With HBV-DNA < 400 Copies/mL | Week 72 | — |
| Percentage of Anti-HBe Positive Participants | Week 48 and Week 72 | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported. |
| Percentage of HBeAg Negative Participants | Week 48 and Week 72 | HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported. |
| Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants | Week 48 and Week 72 | HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported. |
Countries
Estonia, Latvia, Lithuania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a |
|---|---|
| Age, Continuous | 36.28 years STANDARD_DEVIATION 13.141 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Time frame: Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL | 6 participants |
Primary
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Time frame: Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) | 6 participants |
Secondary
Mean Alanine Aminotransferase (ALT) Concentrations
Time frame: Week 48 and Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a | Mean Alanine Aminotransferase (ALT) Concentrations | Week 48 | 62.6 international units per liter (IU/L) | Standard Deviation 5.1 |
| Peginterferon Alfa-2a | Mean Alanine Aminotransferase (ALT) Concentrations | Week 72 | 64.5 international units per liter (IU/L) | Standard Deviation 12 |
Secondary
Number of Participants With HBV-DNA < 400 Copies/mL
Time frame: Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of Participants With HBV-DNA < 400 Copies/mL | 4 participants |
Secondary
Percentage of Anti-HBe Positive Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.
Time frame: Week 48 and Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Percentage of Anti-HBe Positive Participants | Week 48 (n= 17) | 41 percentage of participants |
| Peginterferon Alfa-2a | Percentage of Anti-HBe Positive Participants | Week 72 (n= 18) | 33 percentage of participants |
Secondary
Percentage of Anti-HBs Positive Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.
Time frame: Week 48 and Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Percentage of Anti-HBs Positive Participants | Week 48 (n= 36) | 8 percentage of participants |
| Peginterferon Alfa-2a | Percentage of Anti-HBs Positive Participants | Week 72 (n= 35) | 3 percentage of participants |
Secondary
Percentage of HBeAg Negative Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.
Time frame: Week 48 and Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Percentage of HBeAg Negative Participants | Week 72 (n= 21) | 29 percentage of participants |
| Peginterferon Alfa-2a | Percentage of HBeAg Negative Participants | Week 48 (n= 20) | 25 percentage of participants |
Secondary
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.
Time frame: Week 48 and Week 72
Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants | Week 48 | 3 percentage of participants |
| Peginterferon Alfa-2a | Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants | Week 72 | 3 percentage of participants |