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Trial record 14 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02777814
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
There has been no report on whether the patients with colorectal 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 colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Entecavir Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Colorectal Cancer Who Are Inactive Hepatitis B Carriers
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Prophylactic Entecavir
Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily
Drug: Entecavir
anti hepatitis B virus
Other Name: Entecavir Dispersible Tablets
Active Comparator: Preemptive Entecavir
Entecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily
Drug: Entecavir
anti hepatitis B virus
Other Name: Entecavir Dispersible Tablets


Outcome Measures

Primary Outcome Measures :
  1. Incidence of hepatitis B virus associated hepatitis [ Time Frame: through study completion, an average of 1 year ]
    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 :
  1. Incidence of hepatitis B virus reactivation [ Time Frame: through study completion, an average of 1 year ]
    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.

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


Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with age between 18 and 75
  2. Patient with histology-proven colorectal 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

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): NCT02777814


Contacts
Contact: Rui-hua Xu, M.D. Ph.D. +86-20-87343295 xurh@sysucc.org.cn
Contact: Feng Wang, M.D. Ph.D. +86-18620880867 fengwang@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, M.D. Ph.D. Sun Yat-sen University
More Information

Publications:
Responsible Party: Ruihua Xu, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02777814     History of Changes
Other Study ID Numbers: CRC-HBV
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ruihua Xu, Sun Yat-sen University:
colorectal cancer
Entecavir
Hepatitis B Carrier

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