Clinical Trial: A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)

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.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Percentage of Participants with Normal Alanine Aminotransferase (ALT) and Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) [ Time Frame: At Week 72 ]

Current Secondary Outcome:

  • Percentage of Participants With Normal ALT at Week 48 [ Time Frame: 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 Negative HDV RNA at Week 48 [ Time Frame: 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.
  • Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 [ Time Frame: 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 [ Time Frame: 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 HBsAg Seronegative at Weeks 48 and 72 [ Time Frame: 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 Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 [ Time Frame: 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.


Original Secondary Outcome:

  • Percentage of Participants with Normal ALT and Negative HDV RNA [ Time Frame: At Week 48 ]
  • Percentage of Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 copies/milliliter (mL) [ Time Frame: At Weeks 48 and 72 ]
  • Absolute Hepatitis B Surface Antigen (HBsAg) Levels [ Time Frame: At Weeks 48 and 72 ]
  • Percentage of Participants with HBsAg Seronegative and Positive Hepatitis B Surface Antibody (HBsAb) [ Time Frame: At Weeks 48 and 72 ]


Information By: Hoffmann-La Roche

Dates:
Date Received: April 5, 2016
Date Started: October 2005
Date Completion:
Last Updated: July 15, 2016
Last Verified: July 2016