Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

Leprosy Clinical Trial

Official title:

A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919451
• Other study ID #: ITCRBY24-T1RB
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2009
• Last updated: March 24, 2015
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review CommitteeEthiopia: Ethiopia Science and Technology CommissionEthiopia: Drug Administration and Control Authority
• Study type: Interventional

Clinical Trial Summary

Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy

Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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)

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		at 24 weeks and 32 weeks	No
Secondary	incidence of adverse effects		throughout 32 weeks	Yes
Secondary	Skin lesion inflammation improvement		up to 36 weeks	No
Secondary	rate of improvement of reaction		up to 36 weeks	No
Secondary	Time to next reactional episode		up to 2 years	No
Secondary	extra prednisolone needed to control reaction		up to 36 weeks	No