Clinical Trial: An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg
Brief Summary: This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
- Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection [ Time Frame: approximately 3.5 years ]
- Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment [ Time Frame: approximately 3.5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D [ Time Frame: approximately 3.5 years ]
- Proportion of chronic hepatitis D patients with liver cirrhosis [ Time Frame: approximately 3.5 years ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: May 2, 2013
Date Started: March 2011
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
