Trial record 26 of 504 for:    hepatitis b | Open Studies

Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02777801
First received: April 1, 2016
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
There has been no report on whether the patients with gastric cancer who are also inactive Hepatitis B carriers should receive prophylactic use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.

Condition Intervention Phase
Stomach Neoplasms
Drug: Entecavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Incidence of hepatitis B virus associated hepatitis [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: Yes ]
    Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level


Secondary Outcome Measures:
  • The incidence of hepatitis B virus reactivation [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: Yes ]
    Reactivation of HBV is defined as a 10-fold or greater increase in the HBV DNA level or an absolute increase of 10^5 copies/mL or greater compared with the baseline value.

  • Interruption of chemotherapy due to hepatitis [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: Yes ]
    Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.


Estimated Enrollment: 50
Study Start Date: June 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylactic Entecavir
use of entecavir in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.
Drug: Entecavir
anti-HBV
Other Name: Entecavir Dispersible Tablets
Active Comparator: Preemptive Entecavir
use of entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus are more than 100 IU/ml till 6 months after the end of chemotherapy.
Drug: Entecavir
anti-HBV
Other Name: Entecavir Dispersible Tablets

Detailed Description:
Patients with gastric cancer who are also inactive hepatitis B carriers are enrolled and randomized into two groups as following. Patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.Patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus are more than 100 IU/ml till 6 months after the end of chemotherapy.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with age between 18 and 75
  2. Patient with histology-proven gastric adenocarcinoma.
  3. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
  4. Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
  5. Patients with at least 6 months' life expectancy from date of recruitment
  6. Patients with positive Hepatitis B Surface-antigen (HBsAg)
  7. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
  8. Patients with negative HBV-DNA
  9. Patients with no known history of radiological &/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
  10. Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
  11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment
  12. patients who sign the informed consent
  13. Patients with good compliance during chemotherapy and follow-ups

Exclusion Criteria:

  1. Patients planned for radiation or radionuclide therapy
  2. Pregnant female patients
  3. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
  4. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
  5. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
  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: NCT02777801

Contacts
Contact: Rui-hua Xu, PHD,MD +86 13922206676 xurh@sysucc.org.cn
Contact: Feng Wang, PHD,MD +86 18620880867 wangfeng@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Feng Wang         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Rui-hua Xu, PHD,MD Sun Yat-sen University
  More Information

Publications:
Responsible Party: Ruihua Xu, Prof, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02777801     History of Changes
Other Study ID Numbers: GC-HBV 
Study First Received: April 1, 2016
Last Updated: May 17, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
gastric cancer
hepatitis B carrier
entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Stomach Neoplasms
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2016