NCT00919815

Brief Summary

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

June 11, 2009

Last Update Submit

March 21, 2015

Conditions

Leprosy

Keywords

LeprosyType 1 ReactionsPrednisoloneCiclosporin

Outcome Measures

Primary Outcomes (1)

  • improvement in nerve function and Clinical Severity Score

    at week 4, 20, 28

Secondary Outcomes (6)

  • Incidence of adverse events

    up to 36 weeks

  • Number of T1R recurrence episodes per patient in each treatment arm

    up to 36 weeks

  • Severity of T1R recurrence for patients in each treatment arm

    up to 36 weeks

  • extra prednisolone needed to control reaction

    up to 36 weeks

  • 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm

    36 weeks

  • +1 more secondary outcomes

Study Arms (2)

ciclosporin arm

EXPERIMENTAL

ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)

Drug: Ciclosporin

prednisolone

ACTIVE COMPARATOR

standard course of prednisolone given in a reducing regimen over 24 weeks

Drug: Prednisolone

Interventions

CiclosporinDRUG

Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Also known as: Cyclosporine, Cyclosporine A
ciclosporin arm
PrednisoloneDRUG

prednisolone 40mg daily then reducing regimen over 24 weeks

Also known as: corticosteroids
prednisolone

Eligibility Criteria

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

You may qualify if:

  • Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
  • Aged 18-65
  • Weigh more than 30Kg

You may not qualify if:

  • Unwillingness to give informed consent
  • Patients with severe active infections such as tuberculosis
  • Pregnant or breastfeeding women (see Appendix II)
  • Those with renal failure, abnormal renal function, hypertensive
  • Patients taking thalidomide currently or within the last 3 months
  • Patients not willing to return for follow-up
  • Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
  • HIV positive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alert Hospital

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Leprosy

Interventions

CyclosporinePrednisoloneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Diana Lockwood, MBChB

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

ET(1)