A Clinical study to compare effects and safety of Recombinant Human Thrombopoietin (rhTPO) Injection with Romiplostim injection in Indian Patients with Immune Thrombocytopenia
- Conditions
- Immune thrombocytopenic purpura,
- Registration Number
- CTRI/2020/06/025707
- Lead Sponsor
- Eris Lifesciences Ltd
- Brief Summary
This study is A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia.
The Primary endpoints are:
1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and absence of bleeding between two groups.
2.Compare the response rate ; Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups
3.Compare the total response rate between two groups.
The Secondary endpoints are:
1.Compare the maximum value and increment in platelet count between two groups
2.Compare the frequencies and total volume of platelet transfusion between two groups
3.Observe the time of platelet count to complete response (reaching ≥100×109/L) and maintenance duration.
4.Occurrence of non neutralizing or neutralizing TPO antibodies.
Safety Endpoint
1.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 108
- Male and Female, aged 18 to 65 years old 2.
- Meeting the following criteria of ITP: a.
- Thrombocytopenia by repeated lab tests.
- Bone marrow examination shows megakaryocyte count increasing or at normal level with dysmaturity.
- Patients with Platelet count ≤ 20×109/L at any time during the screening period, who are non-responsive to standard or high-dose glucocorticoids.
- Patients without splenectomy.
- Patients willing to give written validinformed and signed consent.
- Pregnant or lactating women or patients not willing to adopt contraceptive measures during the trial.
- Patient with Thrombosis history.
- Patients with a diagnosis of secondary thrombocytopenia.
- Patients with hepatorenal dysfunction (serum transaminase and bilirubin are over 1.5 folds of normal upper limit, and creatinine ≥1.5mg/dl).
- Patients with severe cardiorespiratory dysfunction.
- Patients who have active malignancy.
- Patient with hypersensitivity to study drug or any of its excipients.
- Patients on other thrombopoietin receptor agonists (Eltrombopag) as they compete with TPIAO for TPO receptor binding.
- Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- 10.Patients with suspected inability to comply with the study procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and 14 days absence of bleeding between two groups. 14 days 2. Compare the response rate ;Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups 14 days 3.Compare the total response rate between two groups. 14 days
- Secondary Outcome Measures
Name Time Method 1.Compare the maximum value and increment in platelet count between two groups 2.Compare the frequencies and total volume of platelet transfusion between two groups 5.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters 28 days 4.Occurrence of non neutralizing or neutralizing TPO antibodies. 28 days
Trial Locations
- Locations (19)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences, Bhubaneswar
🇮🇳Khordha, ORISSA, India
Aman Hospital and Research Centre,
🇮🇳Vadodara, GUJARAT, India
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Columbia Asia Referral Hospital Yeshwanthpur
🇮🇳Bangalore, KARNATAKA, India
KLE Dr Prabhakar Kore Hospital and MRC
🇮🇳Belgaum, KARNATAKA, India
Lilavati Hospital and Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
Mahatma Gandhi Missions Medical College & Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Mazumdar Shaw Medical center, A unit of Narayana Hrudayalaya Ltd
🇮🇳Bangalore, KARNATAKA, India
Meenakshi Mission Hospital and Research Centre
🇮🇳Madurai, TAMIL NADU, India
Scroll for more (9 remaining)All India Institute of Medical Sciences🇮🇳Delhi, DELHI, IndiaDr Tulika SethPrincipal investigator9811262092drtulikaseth@gmail.com