HBsAg clearance with pegylated interferon and tenofovir combination

HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alpha 2a to ongoing tenofovir treatment: an open-label randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12811193

Enrollment

Registered

2016-08-26

Start date

2013-04-16

Completion date

Unknown

Last updated

2016-10-24

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

Conditions

Chronic hepatitis B Infections and Infestations

Interventions

Patients with chronic hepatitis B (HBV) who were being treated with Tenofovir for more than six months and whose HBV DNA has been below 2000 IU/ml were eligible for recruitment. These patients were ra

these patients also continued Tenofovir 300 mg orally. The group A patients had clinic visits at week 2, week 4, week 12, week 24, week 36, and week 48

and then six monthly for one more year. Group B patients were treated with tenofovir alone. Patients were seen every three months in the first year and then six monthly in the second year. Patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients above 18 years of age 2. Chronic HBV patients receiving Tenofovir 300 mg orally daily for a minimum of 6 months 3. HBeAg-positive or HBeAg-negative patients 4. HBV DNA <2000 IU/ml before recruitment 5. HBsAg should be positive, and HBsAg titer should be measurable from the serum

Exclusion criteria

Exclusion criteria: 1. Side effects to medications or previous intolerance to Tenofovir or Peg IFN 2. Impaired renal function with a GFR <50 3. Hemoglobin <12 gm/L in women and <13 gm/L in men 4. Severe thrombocytopenia: platelets <75000 5. Neutropenia absolute neutrophil count (ANC)< 1000 6. Combined infection with HCV, HIV, HDV 7. Drug-induced, alcohol related or autoimmune liver disease 8. Patients with severe depression or other significant psychiatric illness 9. Previous history of lactic acidosis 10. Advanced cardiac, pulmonary, renal or neurological diseases 11. Liver cirrhosis with Child score (CTP) seven and above 12. Decompensated cirrhosis 13. Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
HBsAg clearance and development of anti-HBs antibodies, measured at regular periods before, during and after the trial period	—

Secondary

Measure	Time frame
Correlation between HBsAg clearance and HBsAg levels at different stages of the study period (pretreatment, on treatment and end of treatment HBsAg level)	—

Countries

Saudi Arabia

Outcome results

None listed

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