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

NCT02777814 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	UNKNOWN
Enrolment	50
Start date	2015-05-01
Completion	2019-11

Conditions

• Colorectal Neoplasms

Interventions

• Entecavir

Primary outcomes

• Incidence of hepatitis B virus associated hepatitis — 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

Countries

China