A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis

Asian Institute Of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis Due to Hepatitis B

Treatments: Drug: Tenofovir; Drug: Entacavir

Study type: Interventional

Funder types: Other

Identifiers

NCT02238860

AIMS-hep B-123

Details and patient eligibility

About

Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.

Full description

The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age (18 years- 70 years)
• Hbv surface antigen positive > 6 months
• HbeAg (positive or negative both)
• Hbv DNA 10^3
• ALT ULN
• No evidence of HCC
• Platelets count > 30 thousands
• CTP score > 7
• Hepatic encephalopathy (grade 1 - 2 only)
• No prior Drug resistance

Exclusion criteria

• Age < 18 years
• HCC patients
• Prior drug resistance
• Current HE > 2
• Solid organ transplantation
• Inadequate hematological function
• Co infection with hepatitis C and HIV
• Autoimmune disorders
• Pregnancy and Breast feeding
• Other hepatic diseases
• Patients on immunosuppressant or chemotherapy agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Entacavir

Active Comparator group

Description:

Entacavir 0.5 mg (OD) for 48 weeks

Treatment:

Drug: Entacavir

Drug: Tenofovir

Tenofovir

Active Comparator group

Description:

Tenofovir 300 mg ,OD for 48 weeks

Treatment:

Drug: Entacavir

Drug: Tenofovir