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CTRI Number  CTRI/2012/03/002511 [Registered on: 22/03/2012] Trial Registered Prospectively
Last Modified On: 16/07/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to evaluate the efficay, safety and tolerability of tafenoquine in subject with Plasmodium vivax malaria 
Scientific Title of Study   TAF112582-A Multi- centre, double-blind, randomised, parallel-group, active-controlled study to evaluate the efficacy, safety and tolerability of tafenoquine (SB-252263,WR238605) in subjects with Plasmodium vivax malaria. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RM2010/00052/03  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sadhna Joglekar 
Designation  Executive Vice President, Medical and Clinical Operations  
Affiliation  GlaxoSmithKline Pharmaceuticals Ltd 
Address  252 Glaxo House Dr.Annie Besant Raod, Worli Mumbai

Mumbai
MAHARASHTRA
400030
India 
Phone  02224959405  
Fax  0224947415  
Email  sadhna.j.joglekar@gsk.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeroze Dalal 
Designation  General Manager, Clinical Operations 
Affiliation  GlaxoSmithKline Pharmaceuticals Ltd 
Address  252 Glaxo House Dr.Annie Besant Road, Worli Mumbai

Mumbai
MAHARASHTRA
400030
India 
Phone  02224959395  
Fax  02224947415  
Email  jeroze.j.dalal@gsk.com  
 
Source of Monetary or Material Support  
GlaxoSmithKline Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  GlaxoSmithKline Pharmaceuticals Ltd 
Address  252 Glaxo House Dr.Annie Besant Road, Worli Mumbai 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh
Brazil
India
Peru
Thailand  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhanpat K Kochar  Kothari Medical And Research Institute   Research Department, Department of Medicines, Kothari Medical & Research Institute Kothari Hospital Marg, Gajner Road, Bikaner.
Bikaner
RAJASTHAN 		 0151-2523454
0151-2201119
drdkkochar@yahoo.com 
Dr KShiva Raju  Krishna Institute of Medical Sciences  1-8-31/1,Minister Road,Secunderabad
Hyderabad
ANDHRA PRADESH 		 09848510401

shivaraju.doctor@gmail.com 
Dr Sandeep Kumar Gupta  M.V. Hospital And Research Centre  314/30, Mirza Mandi, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 0522-2258215
0522-4016051
sandeepkumar.gupta@rediffmail.com 
Dr Anup Anvikar  National Institute of Malaria Research  Epidemilogical & Clinical Research Division, Sector 8, Dwarka
New Delhi
DELHI 		 011-25361090
011-25361090
anvikar@rediffmail.com 
Dr Sanjay Kumar Kochar  S.P. Medical College & A.G. Hospitals  Department of Medicines,Bikaner, Rajasthan-334003
Bikaner
RAJASTHAN 		 09460128222

drskkochar@rediffmail.com 
Dr Preetam Arthur  Sri Ramchandra Medical Centre  Department Of Medicines,No.1,Ramchandra Nagar,Porur,Chennai-600116
Chennai
TAMIL NADU 		 09336077839

Preetam_arthur@yahoo.co.in 
Dr B H Krishnamurthy Rao  Wenlock District Government Hospital  Department of Medicine, Wenlock District Hospital, Mangalore
Bangalore
KARNATAKA 		 0824-2411140
0824-2411140
raobhk@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committtee S.P.Medical College And A.G.Hospitals  Approved 
Institutional Ethics Committee For Kasturba Medical College  Approved 
Institutional Ethics Committee for KIMS Foundation & Research Centre  Approved 
Institutional Ethics Committee For M.V.Hospital and Research Centre  Approved 
Institutional Ethics Committee NIMR   Approved 
Institutional Ethics Committee Sri Ramachandra University  Approved 
Kothari Medical and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Malaria with Plasmodium vivax,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chloroquine  Commercially available generic chloroquine tablets containing 500 mg chloroquine phosphate (equivalent to 300 mg chloroquine free base) will be dosed orally once daily for three days starting on Day 1 of the study. 
Comparator Agent  Primaquine  Commercially available primaquine containing primaquine phosphate USP 26.3 mg (equivalent to primaquine base 15 mg) will be given as a 14-dose course administered orally once daily for 14 days starting from Day 2 of the study. 
Comparator Agent  Primaquine Placebo  Since it is a double-blind, double-dummy study placebo to match primaquine will be given as a 14-dose course administered orally once daily for 14 days starting from Day 2 of the study. 
Intervention  Tafenoquine (100 mg)  Tafenoquine 100 mg will be dosed orally once on either Day 1 or Day 2 of the study as soon as all screening test results are known and entry criteria met. 
Intervention  Tafenoquine (300 mg)  Tafenoquine 150 mg 2 capsules will be dosed orally once on either Day 1 or Day 2 of the study as soon as all screening test results are known and entry criteria met. 
Intervention  Tafenoquine (600 mg)  Tafenoquine 150 mg 4 capsules will be dosed orally once on either Day 1 or Day 2 of the study as soon as all screening test results are known and entry criteria met. 
Comparator Agent  Tafenoquine Placebo  Since it is a double-blind, double-dummy study placebo to match tafenoquine will be dosed orally once on either Day 1 or Day 2 of the study. 
Intervention  Tafenoquine(50 mg)  Tafenoquine 50 mg will be dosed orally once on either Day 1 or Day 2 of the study as soon as all screening test results are known and entry criteria met. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the IB/IB supplement(s), and locally approved prescribing information for CQ and PQ.
Subjects eligible for enrolment in the study must meet all of the following criteria:
Positive Giemsa smear for P. vivax
Parasite density >100 and <100000
Age: ≥16 years
A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of:
non-child bearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or <6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL), pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation with medical report verification, negative pregnancy test or,
child-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug:
Use of oral contraceptive, either combined or progestogen alone used in conjunction with double barrier method as defined below
Use of an intrauterine device with a documented failure rate of <1% per year
Double barrier method consisting of spermicide with either condom or diaphragm
Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female.
Complete abstinence from intercourse for 2 weeks prior to administration of study drug, throughout the study and for a period of 90 days after stopping study drug.
A signed and dated informed consent is obtained from the subject or the subject’s legal representative prior to screening. NB Assent is obtained from subjects <18 years, where applicable and written or oral witnessed consent has been obtained from parent or guardian.
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned
Willing to be hospitalized for 3 days and return to clinic for all follow-up visits including Day 180
QTc <450 msec at screening based on a single QTcF value at screening or as an average of triplicate ECGs obtained over a brief recording period by machine or manual over-read if first is greater than 450 msec
 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria must not be enrolled in the study:
Mixed malaria infections (e.g. identified by Giemsa-stained smear or rapid diagnostic test)
Severe vivax malaria as defined by WHO criteria.
Severe vomiting (no food or inability to take food during previous 8 hours)
Screening haemoglobin (Hb) concentration 7 g/dL.
Glucose 6-phosphate dehydrogenase deficiency, assessed by a quantitative spectrophotometric phenotype assay:
Males: Any subject with an enzyme level 70% of the site median value for G6PD normals will be excluded.
Females: (i) Those females with a screening Hb ≥ 10 g/dL will only be excluded if their enzyme level is 70% of the site median value for G6PD normals.
Those females with Hb ≥7 but 10 g/dL will be excluded if an enzyme level is not 90% of the site median value for G6PD normals.
Liver function test ALT 2 x ULN.
Any clinically significant concurrent illness (e.g. pneumonia, septicaemia), pre-existing conditions (e.g. renal disease, malignancy), conditions that may affect absorption of study medication (e.g. vomiting or severe diarrhoea) or clinical signs and symptoms of severe cardiovascular disease (e.g. uncontrolled congestive heart failure or severe coronary artery disease). These abnormalities may be identified on the screening history and physical or laboratory examination
Subject has taken antimalarials (e.g. ACT, mefloquine, primaquine, chloroquine) or drugs with anti-malarial activity within the past 30 days by history.
History of allergy to chloroquine, mefloquine, tafenoquine, primaquine or to any other 4- or 8-aminoquinolines.
Any contraindications to chloroquine or primaquine administration including a history of porphyria, psoriasis or epilepsy (please refer to chloroquine and primaquine locally approved prescribing information).
Subject who has previously received study medication for this protocol (all parts) or has received treatment with any other investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
History of illicit drug abuse or heavy alcohol intake within 6 months of the study.
Subjects who have taken or will likely require the use of medications from the prohibited medication list (see Appendix 5) which include the following classes:
Histamine-2 blockers and antacids.
Drugs with haemolytic potential.
Drugs known to prolong the QTc interval.

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Relapse efficacy  Relapse efficacy six months post-dosing 
 
Secondary Outcome  
Outcome  TimePoints 
Relapse efficacy   Relapse efficacy four months post-dosing 
Parasite Clearance Time  Time needed to clear asexual parasite from the
blood defined as parasite numbers falling below the limit of detection in the
thick blood smear and remaining undetectable 6-12 hours later. 
Fever Clearance Time  Time from first dose of treatment to the time
when body temperature falls to normal and remains normal for at least 48 hours. 
Time to relapse  Six months post- dosing 
 
Target Sample Size   Total Sample Size="924"
Sample Size from India="450" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  		 17/05/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/09/2011 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Tafenoquine is a new 8-aminoquinoline antimalarial drug being co-developed by GlaxoSmithKline and the Medicines for Malaria Venture with the assistance and historic support of the Walter Reed Army Institute of Research for the radical cure of acute P. vivax malaria in combination with standard doses of chloroquine (CQ). TQ has been shown to be well-tolerated in the treatment and prevention of asmodial infections in pre-clinical models and during Phase 1, 2 and 3 clinical studies in >3000 subjects. Of note, TQ possesses activity against all stages of the Plasmodium lifecycle, including the dormant P. vivax hypnozoite. This study (TAF112582) will be conducted to select an efficacious and well-tolerated TQ dose (Part1) to be co-administered with CQ. Part 2 will investigate the selected TQ/CQ regimen and its safety and efficacy in the treatment and radical cure of P. vivax malaria.

 
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