Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01088659
Eligibility Criteria:
Inclusion Criteria:
* adult patients, \>/=18 years of age
* chronic hepatitis D
* positive for HBsAg \>/=6 months, for anti-HDV \>/=3 months and for HDV-RNA at screening
* negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
Exclusion Criteria:
* antiviral therapy for chronic hepatitis D within the previous 6 months
* previous therapy with pegylated interferon alfa
* treatment with conventional interferon alfa for \>12 months
* hepatitis A or C, or HIV infection
* decompensated liver disease (Childs B-C)
* history or evidence of medical condition associated with chronic liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01088659
Study Brief:
Protocol Section:
NCT01088659