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CTRI Number  CTRI/2018/12/016521 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 13/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Safety and Efficacy of Coversin in adult aHUS subjects 
Scientific Title of Study   A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AK601 3.0 04January2018  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 Preeti Kabra 
Designation  Country Manager 
Affiliation  Medpace Clinical Research India Pvt. Ltd. 
Address  Office No. 1416, 14th Floor, Rupa Solitaire, Building No. A-1, Sector-1, Millenium Business Park, Next to DAKC, Mahape, Navi Mumbai India

Thane
MAHARASHTRA
400701
India 
Phone  2241283900  
Fax    
Email  p.kabra@medpacelab.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Kabra 
Designation  Country Manager 
Affiliation  Medpace Clinical Research India Pvt. Ltd. 
Address  Office No. 1416, 14th Floor, Rupa Solitaire, Building No. A-1, Sector-1, Millenium Business Park, Next to DAKC, Mahape, Navi Mumbai India

Thane
MAHARASHTRA
400701
India 
Phone  2241283900  
Fax    
Email  p.kabra@medpacelab.com  
 
Source of Monetary or Material Support  
Akari Therapeutics Plc 75-76 Wimpole Street, London, W1G 9RT, UK 
 
Primary Sponsor  
Name  Akari Therapeutics Plc 
Address  75-76 Wimpole Street, London, W1G 9RT, UK 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     France
Germany
India
United Kingdom  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay K Agarwal  All India Institutes of Medical Sciences (AIIMS)   Department of Nephrology, 110029-India, Room No 4087, 4th Floor, Teaching Block
New Delhi
DELHI 		 11-26593292

skagarwalnephro@gmail.com 
Dr Valentine Lobo  KEM Hospital  489 Rasta Peth, Sardar Moodliar Road, 411011-India, Renal Unit, II Floor
Pune
MAHARASHTRA 		 9049232489

valentinelobo@rediffmail.com 
Dr Tukaram Jamale  Seth G.S.M.C and KEM hospital  Acharya Donde Marg, 400 012 India, Ward No. 34A, third floor, old hospital building Parel,
Mumbai
MAHARASHTRA 		 9167460362

tukaramjamale@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee, All India Institute of Medical Sciences  Not Applicable 
Institutional Ethics Committee-(IEC-II), Seth GS Medical College and KEM Hospital  Submittted/Under Review 
KEM Hospital Reserch Centre, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D593||Hemolytic-uremic syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coversin (rVA576) powder for solution for subcutaneous injection 18 mg/vial  Powder for solution for injection, Subcutaneous route of administration , Duration-02 Years 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. 18 years and older at the time of consent
2. LDH at screening or at the onset of the current aHUS episode was ≥ 1.5 ULN
3. Platelet count at screening <150 X 109/ L
4. Evidence of AKI as per KDIGO guidelines.
5. Males and females of childbearing potential must agree to use an adequate method of contraception. Females will have a negative serum pregnancy test before entry to the study and throughout the study. Women of child-bearing potential are considered to remain so following menarche until becoming post-menopausal unless permanently sterilised. Permanent sterile methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative cause.
6. The patient has given voluntary written informed consent
7. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the KDIGO guidelines and local standard of care of the PI at each trial site
8. The patient is willing to comply with the process of preparation and self-administration of the study drug 
 
ExclusionCriteria 
Details  1. Thrombotic Thrombocytopenic Purpura (TTP), defined as ADAMTS13 activity <10% from a historical observation (prior to initiation of PT) or as tested at the screening visit.
2. Typical HUS (known Shiga toxin + or positive EHEC culture)
3. HUS related to known HIV infection
4. Identified drug exposure-related HUS
5. HUS related to bone marrow transplant (BMT)
6. HUS related to Cobalamin (vitamin B12) deficiency
7. Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive
8. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease
9. Unresolved meningococcal disease
10. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome
11. Prior use of eculizumab (Soliris®) within 2 months of screening is prohibited
12. Exposure to any other investigational drug acting directly on the complement system within 5 half-lives of screening is prohibited
13. Chemotherapeutic agents within 3 months of enrolment in the study are prohibited
14. History of malignancy within 5 years of screening
15. Known sensitivity to the excipients of meningococcal vaccines, ciprofloxacin or any other antibiotic being administered for purposes of meningitis prophylaxis
16. Participation in other clinical trials within 4 weeks of signing the ICF
17. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects with Normal Platelet count at Day 180   Day 180  
 
Secondary Outcome  
Outcome  TimePoints 
Complete TMA response with preserved renal function and improved renal function. Proportion of subjects with TMA event free status. Time to complete TMA response with improved renal function. Platelet mean count change.Proportion of subjects with Hematologic Normalization.Proportion of subjects with normalisation of platelet count.Proportion of subjects with improvement in renal function.Reduction in requirement for Dialysis. Major Adverse Vascular Events (MAVE) rate.Safety for Coversin.  Day 30, Day 60, Day 90, Day120, Day 150, Day 180. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="4" 
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 
Date of First Enrollment (India)   28/12/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/12/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Atypical Haemolytic Uraemic Syndrome (aHUS) is a rare, genetic, progressive and life threatening disease which results from uncontrolled activation of the complement system leading to thrombotic microangiopathy (TMA) and subsequently severe renal damage, loss of kidney function and sometimes death. The current standard of care in India is plasma exchange or plasma infusion, dialysis, and kidney transplantation. A humanized monoclonal antibody which inhibits the complement system by binding on C5 molecule has shown to be effective in the treatment of aHUS and has been approved for the treatment of aHUS in many countries globally since 2011 but is not available to patients in India currently. Eculizumab has been shown to improve the morbidity and mortality in aHUS patients significantly. 
rVA576 is a naturally derived compound (from tick saliva) that also acts as a complement inhibitor but binds to different site domain on C5 molecule. It is designed to be self-administered via a daily subcutaneous injection. 
The current standard of care in India for aHUS treatment is plasma exchange and dialysis. These treatment options are associated with significant morbidity and mortality and a complement inhibitor therapy has potential to change the treatment pathway for aHUS patients in India. Compared to standard of care of plasma exchange and dialysis, the rVA576 as a terminal complement inhibitor is hoped to improve morbidity and mortality in aHUS patients 
 
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