Clinical Trial: A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

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

Official Title: A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic

Brief Summary: This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment [ Time Frame: Week 96 ]

Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.


Original Primary Outcome: Percentage of Participants with Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment [ Time Frame: At 48 weeks after end of treatment (up to 96 weeks) ]

Current Secondary Outcome:

  • Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment [ Time Frame: Week 48 ]
    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.
  • Number of Participants With ALT Normalization at 48 Weeks After End of Treatment [ Time Frame: Week 96 ]
    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.
  • Number of Participants With ALT Normalization at End of Treatment [ Time Frame: Week 48 ]
    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.
  • Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment [ Time Frame: Week 96 ]
    Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.
  • Number of Participants With Negative HDV RNA at End of Treatment [ Time Frame: Week 48 ]
    Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.


Original Secondary Outcome:

  • Percentage of Participants with ALT Normalization Plus Negative HDV RNA at End of Treatment [ Time Frame: At the end of treatment (up to 48 weeks) ]
  • Percentage of Participants with ALT Normalization at 48 Weeks After End of Treatment [ Time Frame: At 48 weeks after end of treatment (up to 96 weeks) ]
  • Percentage of Participants with ALT Normalization at End of Treatment [ Time Frame: At the end of treatment (up to 48 weeks) ]
  • Percentage of Participants with Negative HDV RNA at 48 Weeks After End of Treatment [ Time Frame: At 48 weeks after end of treatment (up to 96 weeks) ]
  • Percentage of Participants with Negative HDV RNA at End of Treatment [ Time Frame: At the end of treatment (up to 48 weeks) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Continuously during treatment (up to 48 weeks) and through the end of follow-up (up to 96 weeks) ]


Information By: Hoffmann-La Roche

Dates:
Date Received: April 1, 2016
Date Started: September 2004
Date Completion:
Last Updated: June 3, 2016
Last Verified: June 2016