Clinical Trial: The Hepatitis Delta International Network

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Hepatitis Delta Registry and Research Network- Observational Study

Brief Summary: Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

Detailed Summary:

The hepatitis international network cohort is a multicenter, observational study that will build up a research registry of HDV patients all over the world.

The aims of this project are:

i. Collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta.

ii. To better inform patients about their viral infection, present status and evolution of liver disease throughout time. To give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection.

iii. To allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.


Sponsor: HepNet Study House, German Liverfoundation

Current Primary Outcome: Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HDV-RNA HBsAg [ Time Frame: 10 years ]
  • HBV-DNA [ Time Frame: 10 years ]
  • Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]


Original Secondary Outcome: Same as current

Information By: HepNet Study House, German Liverfoundation

Dates:
Date Received: February 19, 2015
Date Started: November 2013
Date Completion: November 2023
Last Updated: August 26, 2015
Last Verified: August 2015