Trial Outcomes & Findings for A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD) (NCT NCT02732639)
NCT ID: NCT02732639
Last Updated: 2016-08-26
Results Overview
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
COMPLETED
PHASE3
31 participants
At Week 72
2016-08-26
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Baseline characteristics by cohort
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Age, Continuous
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38 years
STANDARD_DEVIATION 13.3 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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21 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At Week 72Population: 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.
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
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54.84 percentage of participants
Interval 37.3 to 72.4
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PRIMARY outcome
Timeframe: At Week 72Population: 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.
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
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61.29 percentage of participants
Interval 44.1 to 78.4
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SECONDARY outcome
Timeframe: At Week 48Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Percentage of Participants With Normal ALT at Week 48
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45.16 percentage of participants
Interval 27.6 to 62.7
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SECONDARY outcome
Timeframe: At Week 48Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Percentage of Participants With Negative HDV RNA at Week 48
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64.52 percentage of participants
Interval 47.7 to 81.4
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SECONDARY outcome
Timeframe: At Weeks 48 and 72Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
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.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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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
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83.87 percentage of participants
Interval 70.9 to 96.8
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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
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74.19 percentage of participants
Interval 58.8 to 89.6
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SECONDARY outcome
Timeframe: At Screening and at Weeks 48 and 72Population: 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.
Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
HBsAg Positive at Screening
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31 participants
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Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
HBsAg Positive at Week 48
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29 participants
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Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
HBsAg Positive at Week 72
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26 participants
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SECONDARY outcome
Timeframe: At Weeks 48 and 72Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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|---|---|
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Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Seronegative HBsAg at Week 48
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0 percentage of participants
NA: Not applicable since 0% of participants had negative HBsAg measurements.
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Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Seronegative HBsAg at Week 72
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3.23 percentage of participants
Interval 0.0 to 9.4
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SECONDARY outcome
Timeframe: At Weeks 48 and 72Population: ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.
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.
Outcome measures
| Measure |
Pegylated Interferon (PEG-IFN) Alfa-2a
n=31 Participants
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.
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|---|---|
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Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Positive HBsAb at Week 48
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3.23 percentage of participants
Interval 0.0 to 9.4
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Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Positive HBsAb at Week 72
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3.23 percentage of participants
Interval 0.0 to 9.4
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Adverse Events
Pegylated Interferon (PEG-IFN) Alfa-2a
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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