An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01861444

Enrollment

Registered

2013-05-23

Start date

2011-03-31

Completion date

2015-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis D, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

For epidemiological part of the study: * Adult patients \>/= 18 years of age * Positive HBsAg for at least 6 months For the non-interventional section of the study * Adult patients, \>/= 18 years of age * Positive HBsAg for at least 6 months * Positive anti-delta and positive HDV RNA by PCR * Elevated serum ALT \>/= 2x ULN

Exclusion criteria

Patients with any of the following will not be eligible for treatment with Pegasys: * History of neurological disease * History of severe psychiatric disease * Decompensated diabetes * History of immunologically mediated disease * History of severe cardiac disease * History or other evidence of severe chronic pulmonary disease * Inadequate hematologic function

Design outcomes

Primary

Measure	Time frame
Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection	approximately 3.5 years
Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment	approximately 3.5 years

Secondary

Measure	Time frame
Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D	approximately 3.5 years
Proportion of chronic hepatitis D patients with liver cirrhosis	approximately 3.5 years

Countries

Romania

Outcome results