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Long-Term Safety Of PF-00547659 In Ulcerative Colitis

NCT01771809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2021-06-03

Study results available
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Summary

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

Conditions

Interventions

DRUG

75mg SHP647 (PF-00547659)

75 mg sterile liquid injected subcutaneously every 4 weeks.

DRUG

225mg SHP647 (PF-00547659)

225 mg sterile liquid injected subcutaneously every 4 weeks.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Shire Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-18
Primary Completion
2017-12-13
Completion
2017-12-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain

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 NCT01771809 on ClinicalTrials.gov