To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
Summary
* Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year * Study design:Prospective,Interventional (single arm study) * Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years * Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks * Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month * Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\\1000/mm3 and thrombocytopenia \\500,000/ mm3 are not common unless patients already have cirrhosis
Timeline
- Start
- 2017-03-17
- Primary completion
- 2019-09-17
- Completion
- 2020-09-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | — |