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CTRI Number  CTRI/2025/01/079606 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A research study to evaluate how well etavopivat works in people with sickle cell disease 
Scientific Title of Study   A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease 
Trial Acronym  HIBISCUS 2 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2023-509175-16  EudraCT 
NCT06612268  ClinicalTrials.gov 
NN7535-7807_Version 3.0_Dated 30 September 2024  Protocol Number 
U1111-1298-3431  UTN 
 
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 Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance  
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Novo Nordisk India Private Limited, Nxt Tower 2, Floor 1 and 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli

Bangalore
KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance  
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Novo Nordisk India Private Limited, Nxt Tower 2, Floor 1 and 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli

Bangalore
KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk A/S-Novo Alle, 2880 Bagsvaerd Denmark 
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  Novo Nordisk India Private Limited, Nxt Tower 2, Floor 1 and 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Belgium
Brazil
Canada
Colombia
France
Ghana
Greece
India
Italy
Kenya
Lebanon
Netherlands
Nigeria
Oman
Saudi Arabia
Spain
Turkey
Uganda
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Kumar Kannauje   AIIMS Raipur  Department of General Medicine, Room no 413, D Block, 4th floor, Gate no 4, AIIMS Raipur, Tatibandh, GE Road, Raipur, Chhattisgarh – 492099, India
Raipur
CHHATTISGARH 		 9752696488

drpankajkannauje@aiimsraipur.edu.in 
Dr Tulika Seth  All India Institute of Medical Sciences (AIIMS), New Delhi  Department of Haematology, AIIMS, 5th Floor, Porta Cabin, Academic Block, All India Institute of Medical Sciences (AIIMS), New Delhi - 110029, India
New Delhi
DELHI 		 9811262092

drtulikaseth@gmail.com 
Dr Dipty Jain  Arihant Multispeciality Hospital  Arihant Multispeciality Hospital, Plot No. 34, 35, 36, Rambagh Road, Near Baidyanath Square, opposite capitol heights, opposit VR Mall, Nagpur, Maharashtra 440009
Nagpur
MAHARASHTRA 		 9373103579

diptyjain57@gmail.com 
Dr Damodar Das  Gauhati Medical College & Hospital  Gauhati Medical College And Hospital, Department of Haematology, 3rd floor, Old Buliding, Bhangagarh, Guwahati, Assam - 781032, India
Kamrup
ASSAM 		 8638167301

dasdd18@gmail.com 
Dr Abdul Majeed K  Government Medical College  Government Medical College, Clinical Research Room, Department of General Medicine, Ground Floor, Room No. 27, Opposite OP Pharmacy, Kozhikode, Kerala – 673008, India
Kozhikode
KERALA 		 9447311247

majeedonco@gmail.com 
Dr Seema Bhatwadekar  HOCC Haemato Oncology Care Centre  HOCC Haemato Oncology Care Centre, Kedar, 1st floor, Clinical Research Department, New India Mill compound, Behind Swadia Patel Hospital, Jetalpur Road, Vadodara, Gujarat - 390020, India
Vadodara
GUJARAT 		 9374511709

ssbkar16@gmail.com 
Dr Priyanka Samal  Institute of Medical Sciences and SUM Hospital  Institute of Medical Sciences and SUM Hospital, lower ground floor, Department of Medical Research, K-8,Kalinga Nagar,Ghatikia,Bhubaneswar,751003-Odisha
Khordha
ORISSA 		 8902621993

samalpriyanka80@gmail.com 
Dr Venkatesh CR  JSS Hospital  Department of General Medicine, JSS Hospital, M G Road, Mysuru – 570004, Karnataka, India
Mysore
KARNATAKA 		 9590031812

venkateshcr@jssuni.edu.in 
Dr Dharmesh Vaghasiya  Nirmal Hospital Pvt Ltd  Nirmal Hospital Pvt. Ltd, Basement, Clinical Research Department, Ring Road, Surat, Gujarat – 395002, India
Surat
GUJARAT 		 7767054520

drdharmeshrvaghasiya@gmail.com 
Dr K K Radhika  Nizams Institute of Medical Sciences  Department of Clinical Hematology, Panjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA 		 9494649657

radhika_setti@yahoo.com 
Dr Nita Radhakrishnan  Post Graduate Institute of Child Health  Department of Paediatric Haematology and Oncology, 4th Floor, Post Graduate Institute of Child Health, Sector 30, Noida, Gautam Budh Nagar, Uttar Pradesh - 201303, India
Gautam Buddha Nagar
UTTAR PRADESH 		 9999041433

nitark@gmail.com 
Dr Rupal Dosi  SSG Hospital, Medical College   SSG Hospital, Medical College - Baroda, 6th floor, clinical study room, Department of Medicine, New Emergancy Building, SSG Hospital, Jail Road, Vadodara - 390001, Gujarat, India
Vadodara
GUJARAT 		 9824083734

ssghospital.ct@spearsmind.com 
Dr Mohitkumar Gajendrabhai Desai  Zydus Medical College & Hospital  Department of General Medicine Zydus Medical College & Hospital, Civil Hospital Opp. Nehru Baug, Station Road, Dahod, Gujarat 389151 India
Dohad
GUJARAT 		 9429079659

drmohitdesai@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
IEC IMS and SUM Hospital   Approved 
IEC Rughwani Child Care Centre and Hospital  Approved 
Institute Ethics committee, AIIMS New Delhi  Approved 
INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR  Approved 
Institutional Ethics Committee Govt Medical College Kozhikode  Approved 
Institutional Ethics Committee for Human Research  Approved 
Institutional Ethics Committee GMCH  Approved 
Institutional Ethics Committee Super Speciality Pediatric Hospital & PGTI  Approved 
Institutional Ethics Committee, JSS Medical College JSS Hospital, Mysore  Approved 
NIMS Institutional Ethics Committee  Approved 
Nirmal Hospital Ethics Committee  Approved 
Parikh Institutional Ethics Committee  Approved 
Zydus Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etavopivat  Intervention type: IMP, test product Pharmaceutical form: Tablet Route of administration: Oral Trial product strength: 200 mg per tablet Dose and dose frequency: 400 mg once daily Dosing instructions and administration: 2 tablets daily 
Comparator Agent  Placebo  Intervention type: IMP, reference product Pharmaceutical form: Tablet Route of administration: Oral Trial product strength: Placebo Dosing instructions and administration: 2 tablets daily 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female.
2. Age 12 years or above at the time of signing the informed consent.
3. Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.
4. Have 1 to 15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participants medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.
5. 5. Hb greater than or equal to 5.0 and less than or equal to 10.0 g/dL (greater than or equal to 50 and less than or equal to 100 g/L) at screening. 
 
ExclusionCriteria 
Details  1. More than 15 VOCs within the past 12 months prior to screening documented in the participants medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.
2. Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.
3. Use of a selectin antagonist (eg crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.
4. Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).
5. Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.
6. Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.
7. Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.
8. Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).
9. Hepatic dysfunction characterized by:
- Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or
- Direct bilirubin greater than 3.0 × ULN.
10. Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.
11. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] at screening, calculated by the central laboratory greater than 30 mL/min/1.73 m2) or on chronic dialysis.
12. Travelled distance on standardized 6MWT below 100m at screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary
1 Number of adjudicated VOC events
with a medical contact
Secondary Confirmatory
1 Time to onset of first adjudicated
VOC
2 Change in distance travelled during
the 6-minute walking test (6MWT)
3 Change in standardised T-score on
the PROMIS Fatigue 7a Scale 		 Baseline (week 0) to
week 52 
 
Secondary Outcome  
Outcome  TimePoints 
Change in haemoglobin (Hb)  Baseline (week 0) to
week 52 
Change in Hb greater than 1 g/dL  Baseline (week 0) to
week 52 
Change in lactate dehydrogenase
(LDH) 		 Baseline (week 0) to
week 52 
Change in absolute reticulocyte
count 		 Baseline (week 0) to
week 52 
Change in indirect bilirubin  Baseline (week 0) to
week 52 
Changes in estimated glomerular
filtration rate (eGFR) 		 Baseline (week 0) to
week 52 
Change in albumin:creatinine ratio (ACR)  Baseline (week 0) to
week 52 
Occurrence of moderate/severe
albuminuria (yes/no) 		 Baseline (week 0) to
week 52 
Change in N-terminal pro b-type
natriuretic peptide (NT-pro-BNP) 		 Baseline (week 0) to
week 52 
Proportion of participants achieving
the threshold for clinically
meaningful change (yes/no) in
PROMIS fatigue scale 7a 		 Baseline (week 0) to
week 52 
Proportion of participants achieving
the threshold for clinically
meaningful change (yes/no) in
6MWT 		 Baseline (week 0) to
week 52 
 
Target Sample Size   Total Sample Size="408"
Sample Size from India="100" 
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)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/12/2024 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years. 
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