LeprosyPhase 2NCT00919451
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
A Phase 2 study testing ciclosporin in people with Leprosy, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leprosy
- What is being tested?
- ciclosporin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEthiopia
- Study dates
- Aug 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
- Aged 18-65
- Weigh more than 30Kg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Leprosy
- Being tested
- ciclosporin
- Keywords
- Leprosy, Type 1 Reaction, Prednisolone, Ciclosporin
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclosporinDrug
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
| Study group | Role | What they receive |
|---|---|---|
| Ciclosporin | Experimental | ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks) Receives: Drug: ciclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in nerve function
Measured: at 24 weeks and 32 weeks
Secondary outcomes (5)
incidence of adverse effects
Measured: throughout 32 weeks
Skin lesion inflammation improvement
Measured: up to 36 weeks
rate of improvement of reaction
Measured: up to 36 weeks
Time to next reactional episode
Measured: up to 2 years
extra prednisolone needed to control reaction
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startAug 2010
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Diana NJ Lockwood, MBChB, Principal investigator, London SHTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919451
- Sponsor's protocol ID
- ITCRBY24-T1RB
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2009
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00919451
- Acronym / sponsor ID
- ITCRBY24-T1RB
- Conditions
- Leprosy
- Keywords
- Leprosy, Type 1 Reaction, Prednisolone, Ciclosporin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciclosporin | Experimental | Drug: ciclosporinciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
- Aged 18-65
- Weigh more than 30Kg
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciclosporinCiclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks) | Drug | Ciclosporin |
Primary outcome
improvement in nerve function
Time frame: at 24 weeks and 32 weeks
5 secondary outcomes
incidence of adverse effects
Time frame: throughout 32 weeks
Skin lesion inflammation improvement
Time frame: up to 36 weeks
rate of improvement of reaction
Time frame: up to 36 weeks
Time to next reactional episode
Time frame: up to 2 years
extra prednisolone needed to control reaction
Time frame: up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Related trials for Leprosy
Not yet recruitingPhase 2
Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
Leprosy, Multibacillary
RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Erythema Nodosum Leprosum
RecruitingObservational study
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Atopic Dermatitis, Psoriasis
RecruitingPhase 3
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Leprosy
Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Leprosy, Leprosy Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana NJ Lockwood, MBChB principal investigator
London SHTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ciclosporin in people with Leprosy, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in nerve function (time frame: at 24 weeks and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.