Clinical Trial: HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-N

Brief Summary: Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.

Detailed Summary:
Sponsor: HepNet Study House, German Liverfoundation

Current Primary Outcome: Negativation of HDV-RNA at the end of therapy [ Time Frame: week 96 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Negativation of HDV-RNA at week 48 of treatment [ Time Frame: week 48 ]
  • Negativation of HDV-RNA 24 weeks after the end of treatment [ Time Frame: week 120 ]
  • Normalization of ALT levels at the end of treatment and at the end of follow-up [ Time Frame: week 96 and week 356 ]
  • HDV-RNA-levels over time [ Time Frame: up to week 356 ]
  • Suppression of HBV-DNA below 6 IU/ml using the Cobas TaqMan assay at treatment weeks 48 and 96 and 24 weeks after treatment [ Time Frame: week 48, week 96, week 120 ]
  • Liver histology at end of treatment (Ishak score for inflammation and fibrosis) [ Time Frame: week 96 ]
  • Quantitative HBsAg levels over time. Loss of HBsAg and development of anti-HBs antibodies, intrahepatic cccDNA and HBV-DNA levels over time [ Time Frame: up to week 356 ]
  • HBV- and HDV-virus-specific T cell responses during therapy and after 24 weeks of follow up if virological and biochemical efficacy has been shown [ Time Frame: up week 120 ]
  • Virological long-term outcome [ Time Frame: 1, 2, 3, 4 and 5 years after the end of treatment ]
  • Clinical long-term outcome [ Time Frame: 1, 2, 3, 4 and 5 years after the end of treatment ]
  • Quality of Life [ Time Frame: up to week 356 ]


Original Secondary Outcome: Same as current

Information By: HepNet Study House, German Liverfoundation

Dates:
Date Received: July 3, 2009
Date Started: June 2009
Date Completion: May 2017
Last Updated: April 18, 2016
Last Verified: April 2016