| CTRI Number |
CTRI/2018/06/014682 [Registered on: 29/06/2018] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Phase 3 study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX |
|
Scientific Title of Study
|
ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ALN-AT3SC-003 (Sanofi Genzyme EFC14768) Amndt 2dtd27Jun2018 |
Protocol Number |
| NCT03417102 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Rashmi Chitgupi |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
101, A Wing, Fulcrum, Hiranandani Business Park
Sahar Road, Andheri East,
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Rashmi Chitgupi |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
101, A Wing, Fulcrum, Hiranandani Business Park
Sahar Road, Andheri East, Mumbai 400099
India.
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppdi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sanofi Genzyme, 50 Binney Street, Cambridge, MA 02142, USA |
|
Primary Sponsor
Modification(s)
|
| Name |
Sanofi Genzyme |
| Address |
50 Binney Street, Cambridge, MA 02142, USA
|
| Type of Sponsor |
Other [[Biotechnology Company] ] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceuticals India Private Limited |
101, A Wing, Fulcrum, Hiranandani Business
Park, Sahar Road, Andheri East, Mumbai
400099, Maharashtra, India. |
|
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Countries of Recruitment
|
Australia
Bulgaria
Canada
China
Denmark
France
Germany
Hungary
India
Israel
Italy
Japan
Malaysia
Netherlands
Portugal
Republic of Korea
Russian Federation
South Africa
Spain
Taiwan
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Salvi |
B J Govt. Medical College and Sassoon General Hospital |
3rd Floor, Department of Medicine, Jai Prakash Narayan Road, Pune Railway Station
Pune 411001
Pune
MAHARASHTRA |
919422508154
sonalionly@gmail.com |
| Dr Upendra Sharma |
Bhagwan Mahaveer Cancer Hospital and Research Centre |
Room No. 513, Jawahar Lal Nehru Marg, Jaipur 302017
Jaipur
RAJASTHAN |
919413964612
drupendra.sharma@yahoo.co.in |
| Dr Alok Srivastava |
Christian Medical College |
Room No.2, Department of Haematology, Department Of Neurological Sciences Vellore 632004
Vellore
TAMIL NADU |
914162282352
aloks@cmcvellore.ac.in |
| Dr Savita Rangarajan |
K J Somaiya Hospital and Research Centre |
Somaiya Ayurvihar,
Eastern Express Highway,
Sion East
Pin code - 400022
Mumbai
MAHARASHTRA |
919619525341
rangarajansavita@gmail.com |
| Dr Shailendra Prasad Verma |
King George Medical University |
Room No. 505, 5 floor, Chowk Erstwhile Chhatrapati Shahuji Maharaj Medical University
Lucknow 226003
Lucknow
UTTAR PRADESH |
919451475843
drspkgmu@rediffmail.com |
| Dr Shashikant Apte |
Sahyadri Super Specialty Hospital |
30C, Karve road, Erandwane, Pune – 411 004,
Maharashtra, India
Mumbai
MAHARASHTRA |
919822404983
912025459117
shashikant.apte@gmail.com |
| Dr Ross Cecil Reuben |
St Johns Medical College Hospital |
Room No. 54A, Ground floor, Sarjapur Road, Bangalore 560034
Bangalore
KARNATAKA |
919448493705
cecil.ross@bsnl.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee Silver |
Approved |
| Institutional Ethics Committee Bhagwan Mahaveer Cancer Hospital and Research Centre |
Approved |
| Institutional Ethics Committee of B J Government Medical College and Sassoon General Hospital |
Approved |
| Institutional Ethics Committee, K J Somaiya Medical College and Research Centre |
Approved |
| Institutional Ethics Committee, St Johns Medical College |
Approved |
| Institutionla Ethics Committee |
Approved |
| Sahyadri Hospital Limited Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
•Hemophilia A
•Hemophilia B
, (1) ICD-10 Condition: D689||Coagulation defect, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fitusiran (SAR439774 [formerly Alnylam ALN-AT3SC]) |
In Fitusiran treatment arm, fitusiran 80 mg administered subcutaneously as prophylaxis once monthly, with use of on demand bypassing agents for treatment of breakthrough bleeding episodes |
| Comparator Agent |
On demand bypassing agents |
In On-demand arm, the on-demand bypassing agents for treatment of breakthrough bleeding episodes |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Males, ≥12 years of age
2. Severe hemophilia A or B with inhibitors
◦(Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is ≤2% at Screening; Inhibitors defined as inhibitor titer of ≥0.6 BU/mL or as evidenced by medical records)
3. A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening
4. Willing and able to comply with the study requirements and to provide written informed consent and assent |
|
| ExclusionCriteria |
| Details |
1. Known co-existing bleeding disorders other than hemophilia A or B
2. Antithrombin (AT) activity <60% at Screening
3. Co-existing thrombophilic disorder
4. Clinically significant liver disease
5. Active HCV infection
6. HIV positive with a CD4 count of <200 cells/μL
7. History of arterial or venous thromboembolism
8. Inadequate renal function
9. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)
10. History of intolerance to SC injection(s)
11. Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Annualized bleeding rate (ABR) |
Annualized bleeding rate (ABR): 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Annualized spontaneous bleeding rate
2. Annualized joint bleeding rate
3. Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment |
9 months
9 months
9 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="9"
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 3 |
|
Date of First Enrollment (India)
|
30/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/02/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to determine the frequency of bleeding episodes in adult and adolescent patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK). |