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Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease

NCT01015391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-06-04

No results posted yet for this study

Summary

The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission.

The side effects related to T2 and AZA will also be monitored throughout the study.

Conditions

Interventions

DRUG

T2

1.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops

DRUG

Azathioprine

2.5mg/kg, PO (per oral) one time a day:until progression or unacceptable toxicity develops the first month:1.5mg/kg,PO,one time a day the second month:2.0mg/kg,PO,one time a day since the third month:2.5mg/kg,PO,one time a day

Sponsors & Collaborators

  • Jinling Hospital, China

    lead OTHER

Principal Investigators

  • Weiming Zhu, PhD,MD · General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015391 on ClinicalTrials.gov