Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Leprosy Clinical Trial

Official title:

A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919815
• Other study ID #: ITCRBY24-T1RA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 11, 2009
• Last updated: March 21, 2015
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: London School of Hygiene and Tropical Medicine Ethics CommitteeEthiopia: AHRI/ALERT Ethical Review CommitteeEthiopia: National Science and Technology Committee of EthiopiaEthiopia: Drug Administration and Control Authority
• Study type: Interventional

Clinical Trial 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.

Description:

We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals with clinical evidence of T1R with new nerve function impairment (NFI).

• Aged 18-65

• Weigh more than 30Kg

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leprosy

Intervention

Drug:
• Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
• Prednisolone
prednisolone 40mg daily then reducing regimen over 24 weeks

Locations

Country	Name	City	State
Ethiopia	Alert Hospital	Addis Abeba

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Homes and Hospitals of St Giles

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in nerve function and Clinical Severity Score		at week 4, 20, 28	No
Secondary	Incidence of adverse events		up to 36 weeks	Yes
Secondary	Number of T1R recurrence episodes per patient in each treatment arm		up to 36 weeks	No
Secondary	Severity of T1R recurrence for patients in each treatment arm		up to 36 weeks	No
Secondary	extra prednisolone needed to control reaction		up to 36 weeks	No
Secondary	6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm		36 weeks	No
Secondary	Mean time to recurrence of T1R for patients in each treatment arm		up to 36 weeks	No