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Trial record 116 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Entecavir for Decompensated HBV Cirrhosis

This study is currently recruiting participants.
Verified November 2017 by Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03345498
First Posted: November 17, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanjay Gandhi Postgraduate Institute of Medical Sciences
  Purpose

Entecavir (ETV) and tenofovir (TDF) are the first-line drugs for treatment of chronic hepatitis B virus (HBV) infection. Chronic HBV infection gradually progress to liver cirrhosis. Over time, as liver damage and cirrhosis advance, the illness progress to a stage termed as decompensated cirrhosis, characterized by development of one or more of serious, life-threatening complications (ascites, hepatic encephalopathy, variceal bleeding or jaundice). In HBV related decompensated cirrhosis, antiviral treatment is shown to provide benefit.

For HBV related decompensated cirrhosis, EVT is the drug of choice as it has been shown to be effective and safe. The usual dose of ETV for chronic HBV infection is 0.5 mg orally once daily. Somehow, the recommended dose of ETV for decompensated cirrhosis has been 1.0 mg/d. The literature provides no justification for using this double dose of ETV. Since 0.5 mg daily works well in other stages of disease, there is little reason why it should not work well even in treatment-naïve decompensated cirrhosis. Considering the limitations of available literature, physicians' are divided in their opinion about the drug dose and are prescribing either of the two doses of ETV for this group. Hence, there is a need to assess whether the usual 0.5 mg/d of ETV would work as well as the 1.0 mg/d dose of ETV in decompensated cirrhosis due to HBV infection.

Investigators planned this open-labeled observational study with objective to compare the efficacy of HBV suppression achieved using 0.5 mg daily and 1.0 mg daily of ETV in HBV-related decompensated cirrhosis by comparing the mean reduction in HBV DNA level from baseline after 24 weeks of treatment.

In present study investigators propose to enroll 15 participants in each group who has been started on either doses (0.5 mg and 1.0 mg) of entecavir and measure serum HBV DNA levels in blood specimens (5 ml) will be collected at different time points, i.e. at baseline, 2, 4, 8, 12 and 24 weeks after starting entecavir.


Condition Intervention
Hepatitis B Liver Cirrhosis Drug: Entecavir

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study to Compare Virological Response to 0.5 mg Daily Versus 1.0 mg Daily Oral Doses of Entecavir in Chronic Hepatitis B Virus Infection Related Decompensated Cirrhosis

Resource links provided by NLM:


Further study details as provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:

Primary Outcome Measures:
  • Percent reduction in quantitative HBV DNA levels at 2 weeks post-treatment [ Time Frame: 2 weeks from start of ETV treatment ]
    Quantitative HBV DNA will be measured in study participants at 2 weeks post-treatment in participants receiving either intervention. Percent reduction at 2 weeks from baseline level will be compared between interventions.

  • Percent reduction in quantitative HBV DNA levels at 4 weeks post-treatment [ Time Frame: 4 weeks from start of ETV treatment ]
    Quantitative HBV DNA will be measured in study participants at 2 weeks post-treatment in participants receiving either 0.5 mg or 1.0 mg daily doses of entecavir. HBV DNA will be measured after 2 weeks of ETV. Percent reductions at 4 weeks from baseline level will be compared.


Secondary Outcome Measures:
  • Percent reduction in quantitative HBV DNA levels at 8, 12 and 24 weeks post-treatment [ Time Frame: 8, 12 and 24 weeks from start of ETV treatment ]
    Quantitative HBV DNA will be measured in study participants at 8,12 and 24 weeks post-treatment in participants receiving either intervention. Percent reduction at 8, 12 and 24 weeks from baseline level will be compared between interventions.

  • Change in disease severity as assessed by change in CTP score and change in MELD score [ Time Frame: 24 weeks from start of ETV treatment ]
    Liver disease severity scores (Child-Turcotte-Pughscore and Model for End-stage Liver Disease (MELD) score will be assessed after 24 weeks of either intervention and change in score from baseline level will be compared between interventions


Estimated Enrollment: 30
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ETV 0.5 mg
Group of study participants who were started on 0.5 mg/day of entecavir
Drug: Entecavir
Entecavir is the antiviral drug of choice recommended for hepatitis B virus treatment in presence of decompensated cirrhosis
ETV 1.0 mg
Group of study participants who were started on 1.0 mg/day of entecavir
Drug: Entecavir
Entecavir is the antiviral drug of choice recommended for hepatitis B virus treatment in presence of decompensated cirrhosis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will consider to enroll the participants with HBV related decompensated CLD and is planned for treatment, based on their clinical conditions, with either 0.5 or 1.0 mg daily doses of Entecavir by the treating physician. For those who agree to participate (by signing an informed consent), clinical and laboratory findings (including baseline HBV DNA level) will be recorded.
Criteria

Inclusion Criteria:

  • Participants with decompensated liver cirrhosis and
  • Replicative HBV infection (HBsAg positive, serum HBV DNA titer >100,000 IU/mL) regardless of HBeAg and anti-HBe test results

Exclusion Criteria:

  • prior exposure to NAs or other specific treatment for HBV infection (e.g. pegylated interferon)
  • hepatocellular carcinoma
  • co-infection with any other hepatotropic viruses or HIV
  • acute-on-chronic liver failure as defined by Asia-Pacific Association for the Study of Liver criteria
  • significant alcohol intake or another concomitant hepatobiliary disease
  • expected survival below 4 weeks (e.g. hemodynamic instability, active sepsis, hepatorenal syndrome, etc)
  • use of immunosuppressive medication or
  • portal vein thrombosis.
  Contacts and Locations
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): NCT03345498


Contacts
Contact: Amit Goel, DM +91-522-249-4431 agoel.ag@gmail.com

Locations
India
Sanjay Gandhi Postgraduate Institute of Medical Sciences Recruiting
Lucknow, UP, India, 226014
Contact: Amit Goel, DM    9936275741      
Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
Principal Investigator: Amit Goel, DM Associate Professor, Gastroenterology
  More Information

Responsible Party: Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT03345498     History of Changes
Other Study ID Numbers: 2016-140-IMP-93
First Submitted: October 31, 2017
First Posted: November 17, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Pathologic Processes
Entecavir
Antiviral Agents
Anti-Infective Agents