This trial is active, not recruiting.

Condition hepatitis d, chronic
Sponsor Hoffmann-La Roche
Start date March 2011
End date October 2014
Trial size 45 participants
Trial identifier NCT01861444, ML25581


This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluat e the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepat itis D. Eligible patients treated with Pegasys according to current medical prac tice will be followed until 24 weeks after the end of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.