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The effect of Combination Peg interferon –alpha to Tenofovir versus each one of the treatment modalities alone on Patients with HBeAg-negative: A randomized clinical trial

The effect of Combination Peg interferon –alpha to Tenofovir versus each one of the treatment modalities alone on Patients with HBeAg-negative: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181113041635N1
Enrollment
60
Registered
2019-05-08
Start date
2015-09-23
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Hepatitis B. Chronic viral hepatitis B without delta-agent

Interventions

Intervention 1: Intervention group: Group A: Patients who received the coincided combination of tenofovir (300 mg/day) and Peg- IFNa (180 mcg/week) for 48 weeks. Intervention 2: Intervention group: Gr

Sponsors

vice presidency for siences and technology , Iran national silences foundation
Lead Sponsor
Iran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with the age of 18-65 years Negative Hepatitis B e antigen at baseline Quantifiable serum hepatitis B viral DNA load> 2000 IU/ml At least six months from the initial diagnosis Those with no history of receiving an antiviral drug

Exclusion criteria

Exclusion criteria: Hepatitis C, D and HIV Viruses co-infection Dialysis patients with renal impairment Severe liver diseases History of previous hepatitis B treatment (for at least 30 days) Other liver comorbidities such as Autoimmune Hepatitis Hepatocellular Carcinoma, uncompensated cirrhosis

Design outcomes

Primary

MeasureTime frame
The final end-points were rate of HBV DNA loss<20 IU/ml at week 48. Timepoint: HBV DNA load Will be measured. in the Twelve, Twenty-four, thirty-six and 48 weeks for all patients. Method of measurement: by using of Cobas TaqMan polymerase chain reaction (Roche Diagnostics Basel, Switzerland) by Keyvan Virology Specialty Laboratory (KVSL).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Agah

Iran University of Medical Sciences

agah.sh@iums.ac.ir+98 21 6655 4790

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026