A study to assess Inj. Romiplostim in patients with Low levels of the blood cells that prevent bleeding

Phase 1

Recruiting

Conditions: Immune thrombocytopenic purpura,

Registration Number: CTRI/2017/11/010620

Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary: Immune thrombocytopenia (ITP) is an autoimmune syndrome involving antibody- and cell-mediated destruction of platelets and suppression of platelet production by the bone marrow (BM) megakaryocytes that may predispose to bleeding. Romiplostim is a novel thrombopoiesis stimulating protein that has been developed as a treatment for adults with thrombocytopenia associated with ITP. Romiplostim provides an effective approach for the treatment of ITP. Romiplostim has been approved globally including US, EU, Canada, Australia etc since 2008. Romiplostim has not yet approved in India. Intas Pharmaceuticals has developed biosimilar Romiplostim, which is similar to Innovatorâ€™s product in terms for chemical and preclinical characteristics. Efficacy and safety of Romiplostim manufactured by Intas Pharmaceuticals Ltd has already proven in Indian population in a phase III clinical study. Aim of the current study is to evaluate pharmacokinetics of Romiplostim in Indian population. It is a Prospective, Assessor-blind, Randomized, Parallel group clinical study. The present study will be carried out to generate pharmacokinetics, pharmacodynamics and safety data from 24adult patients (12 patients per arm) of both the genders aged 18 to 65 years (both inclusive) years with chronic refractory ITP at different clinical sites across India. Adult patients of both the genders with chronic refractory ITP will be screened for Inclusion/Exclusion criteria. The study will consist of a 1 week of screening period, dosing on day 0 and 4 weeks of follow-up period. Patients will be screened for eligibility over 1 week period. Physical examination, vital signs, and laboratory testing will be performed at the screening visit. All patients will be given 3 mcg/kg dose of Romiplostim on day 0. Total 25 blood samples (3 mL each) will be collected for pharmacokinetic assessment. Total 7 blood samples will be collected for pharmacodynamics assessment. Pharmacodynamic assessment will be performed at central lab using standard validated method. Safety of the patients will be ensured during entire duration of the study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 24

Inclusion Criteria

Male and Female patients aged between 18 to 65 years (both inclusive) 2.
Patients in good health as determined by past medical history, physical examination, vital signs (Heart rate, blood pressure, respiratory rate and oral body temperature), ECG and laboratory tests at screening 3.
Subject must weigh at least 50 kg to participate in the study and must have body mass index (BMI) within the range of 18-30 kg/m2 4.
Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 3months before enrolment 5.
Have completed at least 1 prior treatment for ITP 6.
Subject (or legally acceptable representative) is willing and able to provide written informed consent 7.
Patient must be able to communicate well with the investigator, adhere to the study visit schedule, understand and comply with all protocol requirements.

Exclusion Criteria

Previously patients have taken romiplostim during last one year 2.
History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder.
Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit 4.
Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc.) within 1 week before the screening visit 5.
Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening visit 6.
Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study 7.
Less than 2 months since major surgery 8.
Pregnant or breast feeding 9.
Use of other investigational drug at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer 10.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 11.
Nursing (lactating) women 12.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means unless they are using acceptable methods of contraception 13.
Fertile males, defined as all males physiologically capable of conceiving offspring unless the subjects agrees to comply with effective contraceptive methods for the entire duration and refrain from fathering a child for at least 3 months following last study drug administration 14.
Smokers (use of tobacco products in the previous 3 months) 15.
Use of any prescription drugs, herbal supplements which are known to interfere with pharmacokinetics or pharmacodynamics of romiplostim 16.
Donation or loss of 400 ml or more of blood or equivalent plasma within 8 weeks prior to initial dosing or longer if required by local regulation 17.
Significant illness within 2 weeks prior to initial dosing 18.
History of immunodeficiency diseases including a positive HIV test result.
A positive HBsAg or Hepatitis C test results 19.
Any other condition that in the opinion of investigator could hamper participation in the study 20.
History of drug or alcohol abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during screening and/or baseline.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetic parameters of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc. in chronic refractory immune (idiopathic) thrombocytopenic purpura patients	Visit 2 to visit 9

Secondary Outcome Measures

Name	Time	Method
1. Assessment safety and tolerability of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc	2. Assessment of pharmacodynamics of Inj. Romiplostim from Intas Pharmaceuticals Ltd. and Inj. Romiplostim of Amgen Inc.

Trial Locations

Locations (7): HCG Hospitals
🇮🇳
Ahmadabad, GUJARAT, India
Kailash Cancer Hospital & Research Center
🇮🇳
Vadodara, GUJARAT, India
N.R.S. Medical College & Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Nirmal Hospital Pvt Ltd.,
🇮🇳
Surat, GUJARAT, India
Paras HMRI HospitalÂ Â
🇮🇳
Patna, BIHAR, India
R K Birla Cancer Centre
🇮🇳
Jaipur, RAJASTHAN, India
Unique Hospital-Multispeciaity &Research Institute
🇮🇳
Surat, GUJARAT, India
HCG Hospitals
🇮🇳Ahmadabad, GUJARAT, India
Dr Eva Bhagat
Principal investigator
09825016858
evabhagat@Yahoo.com