Efficacy and Dose Ranging Study of Seroguard

In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.

Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.

A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.

Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.

A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.

Inclusion criteria

• Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).
• Voluntarily and personally signed and dated Form of Informed Consent.
• Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.

Exclusion criteria

• Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
• Body mass index of 30.0 kg/m2 and more;
• Known hypersensitivity to the test drug components (Seroguard);
• Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
• Refusal to use effective contraception methods throughout the study;
• Positive HIV, RW, HBV or HCV test result;
• Alcohol abuse, drug addiction, and toxicomania (except smoking);
• American Society of Anesthesiologists physical status category III and more (ASA);
• Purulent process in the abdominal cavity;
• Disseminated endometriosis;
• WBC count more than 10*109/L at the complete blood count;
• Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium chloride) administered intraperitoneally in the end of surgery.
• Concomitant diseases that may require conversion of the surgical intervention by other indications;
• Type I or II diabetes mellitus;
• Deep vein thrombosis and/or PATE at the screening or in the medical history;
• Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);
• Liver disorders defined as more than 2-fold rise of the upper limit of normal of one of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin increase;
• Myocardial infarction within 6 months before screening;
• Any concomitant diseases accompanied by heart failure;
• Clinically significant ECG changes (as to the investigator's opinion);
• Any concomitant diseases accompanied by respiratory failure;
• Any oncological disease within 3 years before enrollment into the study;
• Systemic inflammatory diseases;
• Diseases associated with chronic hemorrhages;
• Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);
• Any other disease that, in the investigator's opinion, may affect study results or present an additional threat to well-being of a patient after administration of the study drug;
• Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of less than 325 mg/day) at the moment of inclusion into the study or planning to do so during the study;
• Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;
• Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.
• Participation in any other clinical trial within 30 days before screening;
• Contraindications to MRI (presence of implants or implanted electronic devices);
• Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.