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

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ClinicalTrials.gov Identifier: NCT02238860
Recruitment Status : Unknown
Verified September 2014 by Mohammad sadik memon, Asian Institute Of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mohammad sadik memon, Asian Institute Of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Due to Hepatitis B Drug: Entacavir Drug: Tenofovir Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016


Arm Intervention/treatment
Active Comparator: Entacavir
Entacavir 0.5 mg (OD) for 48 weeks
Drug: Entacavir
Entacavir-0.5 mg ,OD,for
Other Name: ETV

Drug: Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks
Other Name: TDF or PMPA

Active Comparator: Tenofovir
Tenofovir 300 mg ,OD for 48 weeks
Drug: Entacavir
Entacavir-0.5 mg ,OD,for
Other Name: ETV

Drug: Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks
Other Name: TDF or PMPA




Primary Outcome Measures :
  1. Safety and efficacy [ Time Frame: 48 weeks ]
    EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 48 weeks ]
    SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.


Other Outcome Measures:
  1. Outcome [ Time Frame: 48 weeks ]
    Death



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238860


Contacts
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Contact: Dr mohammad sadik Memon, Fcps gastro 022-232593 Sadikmemon@gmail.com
Contact: Madiha Zaki, MSC gastro 022-232593 Madiyaah@gmail.com

Locations
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Pakistan
Asian Institute of medical Sciences Recruiting
Hyderabad, Sindh, Pakistan, 71800
Contact: Dr mohammad sadik Memon, FCPS gastro    022-232593    Sadikmemon@gmail.com   
Principal Investigator: Dr sadik Memon, FCPS gastro         
Sub-Investigator: Dr Madiha Zaki, MSC gastro         
Sub-Investigator: Dr NANDLAL Serani, FCPS gastro         
Sub-Investigator: Dr Umar Soomro, MBBS         
Sponsors and Collaborators
Asian Institute Of Medical Sciences
Investigators
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Principal Investigator: Mohammad sadik Memon, Fcps gastro Aims

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Responsible Party: Mohammad sadik memon, Professor of gastroenterology, Asian Institute Of Medical Sciences
ClinicalTrials.gov Identifier: NCT02238860     History of Changes
Other Study ID Numbers: AIMS-hep B-123
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Mohammad sadik memon, Asian Institute Of Medical Sciences:
Hepatitis B
cirrhosis
Entacavir
enofovir
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents