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Randomized trial of new oral anti hepatitis B drug (entecavir) plus interferon versus another oral anti hepatitis B drug (lamivudine) plus interferon in chronic hepatitis B in children.

Randomized trial of entecavir plus interferon versus lamivudine plus interferon in chronic hepatitis B in children.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/04/006820
Enrollment
40
Registered
2016-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children up to 18 years of age with chronic hepatitis B (HBsAg positive for more than 6 months) Health Condition 2: K768- Other specified diseases of liver

Interventions

Intervention1: Oral drug entecavir plus injection interferon: Entecavir 0.015mg/kg (maximum 0.5mg) per day for 48 weeks and interferon alfa (5MU/m2, three times a week, S/C) or peg interferon alfa (2a

Sponsors

Ujjal Poddar
Lead Sponsor
Department of Pediatric Gastroenterology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children with either immune tolerant or immune reactive HBV will be included:Immune tolerant group: Children: 2-18 years of age of either sex with chronic HBV (HBsAg+ve for more than 24 weeks, HBeAg+ve, anti HBe-ve, DNA > 108IU/ml with normal or near normal ALT (within 2 times ULN) and liver histology shows normal or minimal changes. Immune clearance or immune-reactive group: Children: 2-18 years of age of either sex with chronic HBV (HBsAg+ve for more than 24 weeks, HBeAg+ve, anti HBe-ve, DNA > 20,000 IU/ml but 2 times ULN) and liver histology shows necro-inflammatory activities.

Exclusion criteria

Exclusion criteria: Children less than 2 years of age, co-infection with HCV and HIV, advanced liver disease (decompensated cirrhosis), associated autoimmune diseases, neuropsychiatric illness, low platelet counts ( < 1, 00, 000), low total leucocyte count ( <3, 000), age <24 months, previous history of interferon or antiviral therapy.

Design outcomes

Primary

MeasureTime frame
Primary out come: HBsAg loss or complete cure 6month after completion of 12 months of sequential combo therapy (first 2mo only oral drug and then 10mo of oral plus interferon). Secondary out rate of HBeAg seroconversionTimepoint: Primary out come: HBsAg loss or complete cure with 12 months of sequential combo therapy (first 2mo only oral drug and then 10mo of oral plus interferon). Secondary out rate of HBeAg seroconversion—

Secondary

MeasureTime frame
Secondary out rate of HBeAg seroconversionTimepoint: At the end of therapy that is 12 months and 6 months after stopping therapy—

Countries

India

Contacts

Public ContactUjjal Poddar

Sanjay Gandhi Postgraduate Institute of Medical Sciences

ujjalpoddar@hotmail.com05222494418

Outcome results

None listed

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