Condition category
Circulatory System
Date applied
05/02/2002
Date assigned
05/02/2002
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor PA Bacon

ORCID ID

Contact details

Department of Rheumatology
Division of Immunity & Infection
University of Birmingham Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 6778
p.a.bacon@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B0697

Study information

Scientific title

Acronym

Hi Cy3

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Systemic vasculitis

Intervention

At entry the patients will be randomised to either:
1. The HiCy3 regime (six tapering pulses of cyclophosphamide over 3.5 months, with the first pulse being 1.6 g/m^2)
2. The spCy regime - standard pulse cyclophosphamide (nine pulses of 15 mg/kg over 6 months)

All patients will receive intravenous methyl prednisolone with each cyclophosphamide pulse plus relatively low dose routine oral steroid. All patients will also receive mesna with each cyclophosphamide pulse, and will progress to a low dose azathioprine consolidation regime, given up to the end of month 18 of total study.

Updated 19/05/2014: this trial was stopped for reasons of poor recruitment in 2009.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclophosphamide, methyl prednisolone, mesna, azathioprine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2001

Overall trial end date

30/08/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Patients with newly diagnosed systemic vasculitis
2. Patients with a major recent flare and total previous dose of cyclophosphamide less than 70 g

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2001

Recruitment end date

30/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Rheumatology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes