An observational study in Hepatitis D, Chronic, sponsored by Hoffmann-La Roche. Terminated at 1 site in Romania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Observational
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 45 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys
For epidemiological part of the study:
For the non-interventional section of the study
Exclusion Criteria:
Patients with any of the following will not be eligible for treatment with Pegasys:
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
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
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche