To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.

Hepatitis B Clinical Trial

Official title:

To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03123653
• Other study ID #: ILBS-HBV-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: September 17, 2020

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: September 17, 2020
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU

Exclusion Criteria:

• HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Peg IFN 2b
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha		6 months
Secondary	Loss of HBsAg after 48 weeks of PEG IFN alpha		48 weeks
Secondary	End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN		48 weeks
Secondary	Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy		1 year