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Basiliximab in Moderate to Severe Ulcerative Colitis

NCT00430898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2008-12-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.

Conditions

Interventions

DRUG

Basiliximab

3 doses of 40mg, IV at baseline, week 2, and week 4

Sponsors & Collaborators

  • Cerimon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daniel Levitt, MD, PhD · Cerimon Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Belgium
  • Czechia
  • India
  • Poland
  • Russia
  • Slovakia
  • Ukraine
  • United Kingdom

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 NCT00430898 on ClinicalTrials.gov