Effect of Pegylated Interferon alfa-2a plus Adefovir in the treatment of chronic hepatitis B with genotype D

Comparison of Pegylated Interferon alfa-2a plus Adefovir and Pegylated Interferon alfa-2a alone in the treatment of chronic hepatitis B with genotype D (multicenter study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138711201155N4

Enrollment

Registered

2009-05-02

Start date

2009-03-09

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Chronic hepatitis B. Chronic viral hepatitis B without delta-agent

Interventions

Intervention 1: 180 µg/wk Pegylated Interferon alfa-2a plus 10 mg Adefovir for 48 week. Intervention 2: 180 µg/wk Pegylated Interferon alfa-2a and placebo for 48 week.

Treatment - Drugs

180 µg/wk Pegylated Interferon alfa-2a plus 10 mg Adefovir for 48 week

180 µg/wk Pegylated Interferon alfa-2a and placebo for 48 week

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Presence of hepatitis B for more than 6 month, ALT more than 1/1 normal upper limit and less than 10 ULN, 1810.000 copies/ml. Exclusion criteria: Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study, previous treatment, coinfection with Hepatitis A,C,D viruses or HIV, Severe dysfunction of liver and kidney, pregnancy, breast feeding, refusing to give informed consent .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Response to treatment. Timepoint: 24 week after treatment. Method of measurement: HBV-DNA<200copies/ml measure with PCR.;Response to treatment. Timepoint: 24 week after treatment. Method of measurement: normal level of ALT measure with Biochemical.	—

Secondary

Measure	Time frame
Adverse effects. Timepoint: monthly. Method of measurement: Clinical evaluation and lab tests.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Joukar

Gastrointestinal and liver disease research center

f_jokar@gums.ac.ir+98 13 1553 5116

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026