Clinical trials

Clinical trial – a study involving humans that is conducted to assess the efficacy and safety of a new drug, devices, diagnostic products, treatment regimens, or to expand the indications for the use of an already known drug, devices, diagnostic products and treatment regimens Contacts for information on clinical research conducted in the corporate fund “University Medical Center”: Tel.: +7 (7172) 69-24-71 e-mail: yerdessov.s@umc.org.kz 

№/№	Title	Clinical trial status	Implementation period	Brief description
International clinical trials
1	CAPSTONE: Phase III Confirmatory Assessment Protocol: rVA576 Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in patients with Paroxysmal Nocturnal Haemoglobinuria (PNH))	Completed	2018-2019	Evaluation of the efficacy, safety and tolerability of the innovative drug rVA576 in combination with standard treatment (ST) in comparison with ST in patients suffering from uncontrolled hemolysis associated with paroxysmal nocturnal hemoglobinuria (PNH).
2	The PRINTO Evidence-based Revision of the International League Against Rheumatism (ILAR) Classification criteria for juvenile idiopathic Arthritis.	Ongoing	2019-2023	Revision of the existing JIA ILAR classification criteria based on an evidence-based approach, using clinical and standard laboratory methods available worldwide to identify homogeneous clinical groups and distinguish between those forms of chronic arthritis that are usually observed only in children.
3	International, multicenter, randomized, double-blind, placebo-controlled parallel group study to evaluate the efficacy and safety of 12-week treatment with Actovegin, given intravenously followed by oral administration in patients with chronic obliterating diseases of the lower limb arteries, stage IIB according to the Fontaine classification	Completed	2019-2020	Study of the effectiveness of the drug Actovegin for the symptomatic treatment of PAD stage IIB according to Fontaine’s classification, the effect on the steady increase in walking distance, on the quality of life of patients; evaluation of the safety of Actovegin compared with placebo.
4	PROSPECTIVE NON-INTERVENTIONAL MULTICENTER STUDY EVALUATING BLEEDING INCIDENCE AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH HEMOPHILIA A WITH INHIBITORS AND NON-INHIBITORS TREATED WITH EMICIZUMAB AND OTHER HEMOPHILIA TREATMENTS IN A REAL-LIFE SETTING	Randomization	2021	Analysis of the number of all bleedings for which treatment was carried out based on the average annual bleeding rate (ABR) in patients with hemophilia A by type of treatment in two groups (Cohort A: patients without FVIII inhibitors, Cohort B: patients with FVIII inhibitors) c routine clinical practice.
Domestic clinical trials
5	Clinical study of the functionality and safety of X-ray diagnostics using a stationary digital X-ray apparatus “Insar”	Completed	2020	Assessment of the safety and clinical effectiveness of the medical and operational qualities of the “Insar” apparatus in the medical practice of medical institutions in the Republic of Kazakhstan, an assessment of the capabilities of the “Insar” apparatus for use as a stationary general-purpose radiographic apparatus for the production of X-ray images of various areas of the body.
6	Clinical testing of a new topical drug “A-psorin” for the treatment of vulgar (simple) psoriasis	Ongoing	2020-2021	Evaluation of the efficacy and safety of the topical drug A-psorin for the relief of psoriasis vulgaris symptoms in subjects.
7	An open prospective cohort study of the efficacy and safety of Longidaza®, lyophilisate for solution for injection, 3000 IU, in the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease that developed after COVID-19 complicated by pulmonary manifestations	Ongoing	2021	Comparison of the outcomes of therapy and prevention of post-inflammatory pulmonary fibrosis and interstitial lung diseases that developed after COVID-19 in patients who were prescribed with Longidaza®, a lyophilisate for preparation solution for injection as part of routine clinical practice, with outcomes in patients who underwent follow-up without active treatment.
8	Study of the life expectancy of patients with metabolic syndrome after reduced body weight: a comparative randomized clinical trial	Completed	2018-2020	Study of changes in telomere length in patients with metabolic syndrome after surgical and nonsurgical weight loss.

 

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