The effect of your Irbesartan drug in treatment of hepatitis B and D

The effect of adding Irbesartan to Pegylated Interferon-alpha-2a in Patients With HBeAg Negative Chronic Hepatitis B Co-infected With Hepatitis D

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017071128308N3

Enrollment

Registered

2017-08-08

Start date

2017-12-21

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

Hepatitis B and D. Chronic viral hepatitis B with delta-agent

Interventions

Intervention 1: Intervention group1: Administration of irbesartan tablet 300 mg daily prior to treatment with pegylated interferon alpha-a2 for 24 weeks, followed by pegylated interferon alfa-a2 wee

Treatment - Drugs

Intervention group1: Administration of irbesartan tablet 300 mg daily prior to treatment with pegylated interferon alpha-a2 for 24 weeks, followed by pegylated interferon alfa-a2 weekly at 180mcg al

Intervention group2: Concomitant administration of a daily dose of 300 mg of Irbesartan tablet and 180 mcg pegylated alpha-a2 interferon for 24 weeks, followed by pegylated interferon alfa-a2 weekly

Intervention group3: Treatment with pegylated interferon alfa-a2 weekly at 180mcg alone for 48 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: chronic hepatitis B with HBsAg present at least 6 months before screening and infection with hepatitis D virus as anti-HDV positive antibodies for at least 3 months and positive for HDV-RNA in the screening period; HBeAg negative ; All women with fertility potential should have a negative pregnancy test before enrollment; ability to provide informed written consent to participate in the study.Exclusion criteria: untreated liver disease; co-infection with hepatitis C or HIV; Creatinine clearance <60 ml / min; Patients who are allergic to one of the Irbesartan components; Pregnancy and lactation; Patients with SBP <110 mm Hg or history of hypo tension at any time

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
HBsAg. Timepoint: Before study, 3 months after, 18 months after. Method of measurement: Blood test, in units per milliliter (IU / ml).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Asadollahi Amin

Tehran University of Medical Science

amiyaneh@gmail.com+98 21 6119 2811

Outcome results

None listed

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