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Trial record 122 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Prompt Or Watchful Monitoring for Hepatitis B Virus Related Hepatocellular Carcinoma Without Elevated viRal Load (POWER)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified November 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02308319
First received: November 26, 2014
Last updated: December 2, 2014
Last verified: November 2014
  Purpose

Antiviral therapy for HBV may play an important role here, as a large observation study from Taiwan reported that the use of nucleos(t)ide analogues (NUC) was associated with 33% reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active liver disease should be treated regardless of their impact on HCC recurrence (patients with high serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low level HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence.

In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected patients with low viral load.


Condition Intervention Phase
Carcinoma, Hepatocellular Drug: Tenofovir disoproxil fumarate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 4, Open-Label Study to Investigate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (Viread(R)) in Preventing Hepatocellular Carcinoma Recurrence in Chronic Hepatitis B Virus Infected Patients With Low Viral Load at Baseline Treated With Radiofrequency Ablation or Resection

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Recurrence free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ]
  • New onset ascites, variceal bleeding, hepatic encephalopathy [ Time Frame: 3 years ]
  • Child-Pugh score and MELD score at baseline and at final follow-up [ Time Frame: 3 years ]
  • Reactivation of hepatitis B [ Time Frame: 3 years ]
    Increase in DNA 1log IU/mL at least 4 weeks apart


Estimated Enrollment: 124
Study Start Date: January 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PROMPT
Prompt therapy with Tenofovir disoproxil fumarate (Viread(R)) 300mg p.o
Drug: Tenofovir disoproxil fumarate
300mg q.d. per oral
Other Name: Viread(R)
Watchful monitoring
Wait and treat with Tenofovir disoproxil fumarate (Viread(R)) when active liver disease is present [defined as HBV DNA >2,000 IU/ml and abnormal ALT (>40 IU/ml)]
Drug: Tenofovir disoproxil fumarate
300mg q.d. per oral
Other Name: Viread(R)

Detailed Description:

HCC is a major global health problem, which is the third leading cause of cancer-related deaths, and accounts for 7% of all cancers worldwide. Curative treatment, such as SR, RFA has improved patients prognosis, however, even after successful curative treatment, high rates of disease recurrence limiting overall survival in HCC patients. In this regard, method to reduce HCC recurrence is an essential component of a therapeutic strategy to maximize outcome.

Antiviral therapy for HBV may play an important role here, as a large observation study from Taiwan reported that the use of NUCs was associated with 33% reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active liver disease should be treated regardless of their impact on HCC recurrence (patients with high serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low level HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence.

In the randomized controlled trial by Yin et al, antiviral therapy was also beneficial in Chronic hepatitis B patients with low viral load (HBV DNA < 104 copies/ml). However, there is a need for further validation of their finding for several reasons. First, the baseline characteristics between two groups were not same (more advanced tumors in the control arm). Second, the recurrence rates in the control arm was too high (about 80%), and the number of patients was small (control = 32, antiviral therapy = 22). Third, HBV DNA levels at 6 months was decreased in the antiviral therapy group (3.36 ± 0.68 log10 copies/ml vs. 4.66 ± 1.38 log10 copies/ml), but was not optimal. The used drugs were lamivudine, adefovir plus lamivudine or entecavir 0.5 mg. With more potent antiviral drug, better outcome is expected.

In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected patients with low viral load.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatocellular carcinoma (clinically or histologically)
  • chronic hepatitis B
  • serum HBV DNA < 2000 IU/mL
  • HCC stage BCLC 0 or A
  • treated or will be treated with RFA or surgical resection

Exclusion Criteria:

  • co-infected with HCV, HIV
  • currently using antiviral drug (lamivudine, adefovir, clevudine, tenofovir, entecavir, telbivudine) or interferon
  • other malignancy
  • dialysis
  • pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02308319

Contacts
Contact: Seung Woon Paik, M.D., Ph.D. 82-2-3410-3409 sw.paik@samsung.com
Contact: Dong Hyun Sinn, M.D., Ph.D. 82-2-3410-3012 dh.sinn@samsung.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Seung Woon Paik, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02308319     History of Changes
Other Study ID Numbers: 2014-09-149
Study First Received: November 26, 2014
Last Updated: December 2, 2014

Keywords provided by Samsung Medical Center:
Hepatocellular carcinoma, Recurrence

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
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

ClinicalTrials.gov processed this record on September 21, 2017