| CTRI Number |
CTRI/2020/09/027702 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treating leprosy patients at high risk of Erythema Nodosum Leprosum (ENL) reaction with additional Clofazimine |
|
Scientific Title of Study
|
Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Vasudev Pai |
| Designation |
Director |
| Affiliation |
Bombay Leprosy Project |
| Address |
Bombay Leprosy Project,
Department of Leprosy, Division – Leprosy Referral Centre, Room no – 1, Ground Floor, Vidnyan Bhavan, 11, V.N. Purav Marg, Sion – Chunabhatti, Mumbai -400 022, India
Bombay Leprosy Project,
Department of Leprosy, Division- Leprosy Training and Research Centre, Room No – 408, 4th Floor, Silver Arch, Bhakti Park CHS, Wadala (East), Mumbai- 400 037, India
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9967944004 |
| Fax |
|
| Email |
bombayleprosy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Vasudev Pai |
| Designation |
Director |
| Affiliation |
Bombay Leprosy Project |
| Address |
Bombay Leprosy Project,
Department of Leprosy, Division – Leprosy Referral Centre, Room no – 1, Ground Floor, Vidnyan Bhavan, 11, V.N. Purav Marg, Sion – Chunabhatti, Mumbai -400 022, India
Bombay Leprosy Project,
Department of Leprosy, Division- Leprosy Training and Research Centre, Room No – 408, 4th Floor, Silver Arch, Bhakti Park CHS, Wadala (East), Mumbai- 400 037, India
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9967944004 |
| Fax |
|
| Email |
bombayleprosy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Kumar Gupta |
| Designation |
Office Executive |
| Affiliation |
Bombay Leprosy Project |
| Address |
Room no. 1, Plot no. 225, DSouza House, Christain Village, Kurla West, Mumbai - 400070
Bombay Leprosy Project,
Department of Leprosy, Division- Leprosy Training and Research Centre, Room No – 408, 4th Floor, Silver Arch, Bhakti Park CHS, Wadala (East), Mumbai- 400 037, India
Mumbai (Suburban)
MAHARASHTRA
400070
India |
| Phone |
9821246526 |
| Fax |
|
| Email |
rahulgulab1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Leprosy Research Initiative c/o Netherlands Leprosy Relief
P.O. Box 95005
Ms. Nicole Dinnissen
1090 HA Amsterdam
The Netherlands
|
|
|
Primary Sponsor
|
| Name |
Leprosy Research Initiative |
| Address |
Leprosy Research Initiative
c/o NLR
Ms. Nicole Dinnissen
Wibautstraat 137k
1097 DN Amsterdam
Netherlands |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Vasudev Pai |
Bombay Leprosy Project |
Department of Leprosy, Division – Leprosy Referral Centre, Room no – 1, Ground Floor, Vidnyan Bhavan, 11, V.N. Purav Marg, Sion – Chunabhatti, Mumbai -400 022, India
Mumbai (Suburban)
MAHARASHTRA |
9967944004
bombayleprosy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BLP Project Committee |
Approved |
| National Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A303||Borderline leprosy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clofazimine |
In Borderline Lepromatous and Lepromatous Leprosy (BL/LL) patients on Multibacillary Multidrug Therapy (MBMDT) or within 12 months of Release from Treatment (RFT), who have or had Erythema Nodosum Leprosum, an “additional clofazimine†means daily dose of 300mg for 8 weeks, then 200mg for 8 weeks, then 100mg for 8 -32 weeks according to tolerance will be administered via the oral route . Those receiving MBMDT will not have routine clofazimine from Blister Calendar Packs (BCPs), neither daily 50mg nor on the day they receive monthly rifampicin (no-one will have more than 300mg on one day). In total participants will receive 48 weeks of Clofazimine. |
| Comparator Agent |
Placebo |
The control group will receive daily dose of vitamin capsules as placebo via the oral route. In total participants will receive 48 weeks of vitamin capsules. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Smear positives cases, i.e. smear positive at diagnosis within 24 months of starting Multibacillary Multidrug Therapy (MBMDT)(as new case, returned defaulter or relapse), i.e. on 12 m fixed duration MBMDT or within 12m of completion of 12m Fixed Duration (FDMBMDT) or on 24m FDMBMDT.
2) People who have or previously had ENL, ENL as defined in ENLIST publications, at any time in past, confirmed by Doctor (physical exam or clinic records), or currently.
3) 1st episode of ENL or recurrent episode (after interval without treatment of>27 days), i.e. exclude chronic ENL (symptoms of ENL and /or treatment for ENL for 24 weeks or more without any interval of >27days)
4) over 18 years old up to 60 years
5)minimum weight 40 kg or BMI>18.5
|
|
| ExclusionCriteria |
| Details |
1)Type 1 reaction, i.e. currently (may occur in BB, BL cases) A past history of type one reaction already fully treated and resolved would not exclude case.
2)Cannot understand about study or lives too far away to attend regularly for follow up, i.e. unable to give truly informed voluntary consent or to cooperate with all assessments
3) Chronic bowel disorder, (e.g. chronic amebic dysentery, ulcerative colitis, irritable bowel syndrome, suspected intestinal TB, malabsorption syndrome etc).
4) Other serious illness likely to interfere with safety or compliance, e.g. HIV, chronic moderate/severe renal impairment, Tb, cancer, uncontrolled type 1 diabetes.
5) Serious adverse effects of steroids in past such as standard regimen in field would not be safe (e.g. GI haemorrhage, glaucoma, steroid-induced psychosis)
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m,
2. to compare the proportion who have recurrence and severity and of ENL over 24 months observation, in those who receive additional clofazimine (at least 100mg/day for 6-12m) with that in those who receive only clofazimine at 50mg /day (or none if RFT).
|
12,24,36,48 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare proportion with increased nerve function impairment in same two groups.
2. To compare the change in health-related quality of life in same two groups.
|
12,24,36,48 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Using un-blinded randomised controlled trial in 2 predominantly-urban community situations (one in India, one in Bangladesh) (using the ENLIST ENL severity scale & the SF36 tool for health-related quality of life for objective outcome measures), we will address the question: 1) 1) Does 6-12m additional clofazimine given to patients who have had at least one episode of ENL, reduce the frequency and severity of ENL over 24 months period? (“additional clofazimine†means daily dose of 300mg for 8 weeks, then 200mg for 8 weeks, then 100mg for 8 -32 weeks according to tolerance) 2) 2) The control group will receive similar-looking capsules of vitamins Placebo (it is impossible to fully blind the trials on account of the skin discoloration associated with high dose of clofazimine). Primary Objective: 1. 1) Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m, 2. 2) To compare the proportion who have recurrence and severity and of ENL over 24 months observation, in those who receive additional clofazimine (at least 100mg/day for 6-12m) with that in those who receive only clofazimine at 50mg /day (or none if RFT). Secondary Objective: 1.To compare proportion with increased nerve function impairment in same two groups. 2. To compare the change in health-related quality of life in same two groups. |