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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Unnamed facility
Bucharest, Romania
Unnamed facility
Bucharest, Romania
Unnamed facility
Cluj-Napoca, Romania
Unnamed facility
Constanța, Romania
Unnamed facility
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
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
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
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
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
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
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Craiova, Romania
Unnamed facility
Iași, Romania
Unnamed facility
Timișoara, Romania
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
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