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

NCT02238860 | Unknown Phase 4

• 1 other identifier: AIMS-hep B-123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis Due to Hepatitis B

Keywords

Hepatitis B; cirrhosis; Entacavir; enofovir

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy

  EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.

  48 weeks

Secondary Outcomes (1)

• Safety

  48 weeks

Other Outcomes (1)

• Outcome

  48 weeks

Study Arms (2)

Entacavir

ACTIVE COMPARATOR

Entacavir 0.5 mg (OD) for 48 weeks

Drug: Entacavir; Drug: Tenofovir

Tenofovir

ACTIVE COMPARATOR

Tenofovir 300 mg ,OD for 48 weeks

Drug: Entacavir; Drug: Tenofovir

Interventions

Entacavir DRUG

Entacavir-0.5 mg ,OD,for

Also known as: ETV

Entacavir; Tenofovir

Tenofovir DRUG

Tenofovir ,300 mg,OD,for 48 weeks

Also known as: TDF or PMPA

Entacavir; Tenofovir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute Of Medical Sciences: lead

Study Sites (1)

Asian Institute of medical Sciences

Hyderābād, Sindh, 71800, Pakistan

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Fibrosis

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohammad sadik Memon, Fcps gastro

  AIMS Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr mohammad sadik Memon, Fcps gastro

CONTACT

022-232593; Sadikmemon@gmail.com

Madiha Zaki, MSC gastro

CONTACT

022-232593; Madiyaah@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of gastroenterology

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

PA (1)