Hepatitis D, Chronic
Conditions
Brief summary
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
Interventions
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening * Positive anti-delta for at least 3 months prior to screening * Positive hepatitis D virus (HDV) ribonucleic acid (RNA) * A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD) * Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
Exclusion criteria
* Antiviral therapy for CHD within the previous 6 months * Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) * Evidence of decompensated liver disease * Other medical condition associated with chronic liver disease * Women with ongoing pregnancy or who are breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | At Week 72 | Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay. |
| Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | At Week 72 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | At Weeks 48 and 72 | Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1\*10\^5 copies/mL. |
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | At Screening and at Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay. |
| Percentage of Participants With Normal ALT at Week 48 | At Week 48 | Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay. |
| Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | At Weeks 48 and 72 | Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg. |
| Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | At Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay. |
| Percentage of Participants With Negative HDV RNA at Week 48 | At Week 48 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pegylated Interferon (PEG-IFN) Alfa-2a |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Time frame: At Week 72
Population: Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | 61.29 percentage of participants |
Primary
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Time frame: At Week 72
Population: Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | 54.84 percentage of participants |
Secondary
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Time frame: At Screening and at Weeks 48 and 72
Population: Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | HBsAg Positive at Screening | 31 participants |
| Pegylated Interferon (PEG-IFN) Alfa-2a | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | HBsAg Positive at Week 48 | 29 participants |
| Pegylated Interferon (PEG-IFN) Alfa-2a | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | HBsAg Positive at Week 72 | 26 participants |
Secondary
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.
Time frame: At Weeks 48 and 72
Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Seronegative HBsAg at Week 48 | 0 percentage of participants |
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Seronegative HBsAg at Week 72 | 3.23 percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1\*10\^5 copies/mL.
Time frame: At Weeks 48 and 72
Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | HBV-DNA at Week 48 | 83.87 percentage of participants |
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | HBV-DNA at Week 72 | 74.19 percentage of participants |
Secondary
Percentage of Participants With Negative HDV RNA at Week 48
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Time frame: At Week 48
Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Negative HDV RNA at Week 48 | 64.52 percentage of participants |
Secondary
Percentage of Participants With Normal ALT at Week 48
Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Time frame: At Week 48
Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Normal ALT at Week 48 | 45.16 percentage of participants |
Secondary
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.
Time frame: At Weeks 48 and 72
Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | Positive HBsAb at Week 48 | 3.23 percentage of participants |
| Pegylated Interferon (PEG-IFN) Alfa-2a | Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | Positive HBsAb at Week 72 | 3.23 percentage of participants |