NCT00947674

Brief Summary

This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2009

Longer than P75 for phase_4

Geographic Reach
6 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

July 27, 2009

Last Update Submit

December 5, 2012

Conditions

Ulcerative Colitis

Keywords

Cellsorba EX

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    at 8th week

Secondary Outcomes (1)

  • Remission, Mayo scores, Mucosal healing, CRP

    at 8th and 16th week

Study Arms (2)

Cellsorba EX

EXPERIMENTAL
Device: Cellsorba EX

Sham treatment

SHAM COMPARATOR
Device: Cellsorba EX

Interventions

Cellsorba EXDEVICE

conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times

Cellsorba EXSham treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy
  • Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically
  • Patients with Mayo score between 5 and 10
  • Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3
  • Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks

You may not qualify if:

  • Patients with a difficulty in peripheral vascular access
  • Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment)
  • Patients with toxic megacolon
  • Patients with a malignant disease or its experience
  • Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA))
  • Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter)
  • Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria
  • Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN
  • Pregnant women or patients with possible pregnancy
  • Breast feeding women
  • Patients weighing 40 kg or less
  • Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL)
  • Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3)
  • Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3)
  • Patients with hypotension (with systolic blood pressure of 80 mmHg or less)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Rostock, Germany

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Oxford, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2012

Study Completion

October 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

DE(2)GB(2)SE(2)JP(2)IL(1)CZ(1)