San Martãn De Porres, Peru
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Phase
2Span
52 weeksSponsor
InflaRx GmbHPleven
Recruiting
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
This study consists of 2 parts: Part A and Part B. Part A: Participants who did not participate in either parent study (TAK-279-3001 [NCT06088043] or TAK-279-3002 [NCT06108544]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B. Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043) or TAK-279-3002 (NCT06108544) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.
Phase
3Span
88 weeksSponsor
TakedaPleven
Recruiting
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.
Phase
3Span
101 weeksSponsor
Alvotech Swiss AGPleven
Recruiting
Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome
Rationale: In this multicenter prospective cohort study, our primary aim is to determine the association of various assisted reproductive technologies (ART) parameters with the perinatal outcome after adjusting for key confounders such as maternal age, BMI, parity and smoking. Our primary outcomes will be small for gestational age neonates, fetal growth restriction, preeclampsia and stillbirth. Additionally, the investigators will examine the association between ART and a range of placental/umbilical abnormalities-such as placenta previa, vasa previa, single umbilical artery, and abnormal cord insertions-and explore how these structural aberrations may act as a mediator. Together, this comprehensive approach is intended to clarify the mechanisms linking ART to adverse obstetric outcomes and ultimately inform improved clinical care and counseling for couples considering ART. Objectives: Primary Objective: To evaluate the association between ART parameters and a series of adverse perinatal outcomes both in singleton and in multiple pregnancies, analyzed as distinct populations. ART pregnancies will be examined both as a collective cohort and within subgroups stratified by specific ART techniques and treatment protocols. Our primary outcomes under investigation: - Small for gestational age neonates defined as <10th percentile. - Fetal growth restriction, either early-onset (<32 weeks) or late-onset (>32 weeks), characterized by an estimated fetal weight below the 3rd percentile or below the 10th percentile based on the Fetal Medicine Foundation (FMF) fetal growth charts accompanied by abnormal Doppler findings; or birthweight below the 5th centile based on the FMF neonatal growth charts - Development of preeclampsia - Stillbirth (intrauterine demise after 22 weeks gestation not attributable to other causes (i.e. congenital infections, structural defects, genetic anomalies) Secondary Objectives: To investigate the relationship between ART and various placental as well as umbilical cord abnormalities (e.g., placenta previa, vasa previa, single umbilical artery, velamentous and marginal cord insertions). All analyses will be adjusted for maternal age, BMI, parity, smoking and other significant confounders depending on the investigated outcome. Methods and analysis: Design, participants and timeframe of enrollment and visits: The study will be a prospective observational cohort that will include all consecutive women above 18 years old who attend for routine ultrasound examination at 11+0 to 13+6 weeks of gestation at one of participating fetal medicine units. The eligibility criteria will be: singleton or multiple pregnancies, with a live fetus at 11+0 to 13+6 weeks, without known genetic anomalies or major fetal defects (such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects) diagnosed before or after birth. All sonographers will be certified for the first-trimester scan by the FMF. Approval will be secured from the ethical committee at each participating center. In every case, written informed patient consent will be obtained. During the initial consultation, maternal height, weight and sociodemographic details such as maternal age, parity, smoking and procedure details in cases of ART conception will be recorded. Detailed demographic information, individual, obstetric, and family history, as well as any complications during the current pregnancy, will be systematically recorded. At each prenatal visit, the investigators will document obstetric ultrasound findings-including fetal growth percentiles, amniotic fluid index, and Doppler measurements-following all protocols recommended by the FMF relevant to the case. Collection of ART Methodology Data: Taking into account our objective, to conduct a detailed analysis of each ART method and parameter in relation to the perinatal outcome, including subgroup analyses based on specific techniques and protocols, the investigators will collect detailed information on ART methods and protocols using a standardized data collection form, which will include the following variables: - Subfertility details: Type of subfertility (primary or secondary) and duration of subfertility. The investigators will document whether the subfertility is due to female factors, male factors, or both. Occurrence of ovarian hyperstimulation syndrome, categorized as mild, moderate or severe will also be recorded, particularly in fresh transfer cycles. - Gamete origin: Source of sperm and oocytes, specifying whether they are from the same individual (autologous) or from a donor. The investigators will also note if the oocytes are fresh or frozen and the donor age. - Culture conditions and media: Details about the embryonic culture environment, including whether an oxygen gradient was used or other specific culture media conditions, will be collected to assess their potential impact on embryo development. - Type of fertilization: The method of fertilization employed, such as conventional IVF or intracytoplasmic sperm injection, will be documented. - Embryo stage at transfer: The developmental stage of embryos at the time of transfer will be recorded, distinguishing between cleavage-stage embryos (day 2-3) and blastocyst-stage embryos (day 5). - Type of embryo transferred: The investigators will specify whether fresh or frozen embryos were transferred during the procedure. - Preimplantation Genetic Testing (PGT): Information on whether preimplantation genetic testing was performed will be collected, including the timing of the testing (day 3 or day 5) and the type of testing, together with any other prenatal or postnatal genetic testing. - Embryo details: The number of embryos available and the number transferred will be noted. The classification and quality of embryos based on morphological and genetic assessments will be recorded. If mosaic embryos were transferred, the investigators will document the levels of mosaicism and any instances of confined placental mosaicism together with any other prenatal or postnatal genetic testing. - Stimulation Protocol: Details of the ovarian stimulation protocol used will be collected, including whether a gonadotropin-releasing hormone (GnRH) antagonist protocol, GnRH agonist long protocol, GnRH agonist short protocol, or GnRH agonist ultra-short protocol was employed. Monitoring and Follow-up: Throughout the pregnancy, any complications such as growth disorders, preeclampsia, stillbirth, gestational diabetes, hypertensive disorders, placental abruption, preterm premature rupture of membranes and spontaneous preterm labor will be closely monitored and recorded. Detailed ultrasonographic assessments of placental and umbilical cord abnormalities (e.g., cord insertion site, number of vessels, placental location) will be performed and recorded, together with details on direct examination at birth and any prenatal or postnatal genetic testing, if available. Even though cases with known genetic anomalies or major fetal defects will be excluded from our primary and secondary analyses, the investigators will systematically record fetal structural anomalies, aneuploidies, and congenital defects based on prenatal ultrasonographic assessments and confirmed postnatally whenever applicable, including findings from genetic testing and direct neonatal examination. Obstetric ultrasound findings, including fetal growth percentiles, amniotic fluid index, and Doppler indices, will be documented at each visit. Following delivery, perinatal outcomes such as gestational age at birth, onset of labor (spontaneous rupture of membranes, contractions, induction, or elective cesarean section), mode of delivery (vaginal or cesarean), birth weight and birth weight percentile according to FMF neonatal percentiles, Apgar scores, and postpartum complications (e.g., postpartum hemorrhage) will be recorded. Data collection: An electronic case record form (CRF) has been specifically designed for this study and incorporated into the clinical software used at the participating centers (ViewPoint® software, GE Healthcare; Munich, Germany or Astraia© software, NEXUS / ASTRAIA GmbH, Ismaning, Germany). Data will be entered prospectively during the study. Access to data included in the CRF will be restricted to the investigators involved in each participating site. Recruitment and power-sample size estimation: For the power analysis, the investigators chose the rarer outcome among our primary outcomes, stillbirth. A relevant prospective cohort reported that the prevalence of stillbirth is 3.7‰ among singleton pregnancies that were conceived naturally, while the risk of stillbirth among IVF-ART pregnancies was 16.2‰. To detect such an increase with a statistical power of 0.80 and a significance level of 0.05, at least 989 ART pregnancies will be needed. After adjusting for a 1:10 ratio of ART pregnancies to spontaneous conceptions, based on data from our study population in previous research, and increasing the sample size by 10% to account for potential losses during follow-up, the investigators determined a required sample size of 1,099 study cases and 10,985 control pregnancies, for a total of 12,084 pregnancies. Data management and statistical analyses: Singleton and multiple pregnancies will be investigated as separate populations. The pregnancies resulting from ART will serve as the study population, while pregnancies from spontaneous conception will form the control group. For every investigated outcome multivariate logistic regression analyses will be conducted, incorporating ART use as an independent variable along with available potential confounding factors. For each analysis, essential confounders will include maternal age, BMI, parity and smoking, while other confounders will be considered based on the individual dependent variable being examined and the decision to include them will be based on clinical relevancy. In addition to multivariate logistic regression, propensity score matching will be employed as a sensitivity analysis for the statistically significant outcomes to further account for confounders. Using the R programming language, the investigators will create propensity scores based on the same confounders used in the logistic regression analyses for each specific outcome. Participants in the ART group will be matched to participants in the spontaneous conception group based on their propensity scores and the balance will be assessed using the standardized mean differences. This matching process aims to balance the distribution of confounders between the two groups, thereby reducing selection bias and providing an alternative estimation of the effect of ART on the outcomes of interest. After matching, statistical tests appropriate for paired data will be employed, depending on the investigated association, as suggested by relevant literature. When feasible, subgroup analyses will be performed to investigate the effects of different ART methods and parameters on the investigated outcomes. The investigators will examine missing data fields to identify the type of missing data mechanisms. Due to the type of outcomes studied, the investigators believe that the majority of missing data will be missing at random; thus, as a sensitivity analysis, multiple imputation technique will be used to impute the missing data. If there are informatively missing data due to clinically relevant events such as death or critical illness the investigators will examine statistical models to account for missing not at random. Adjusted odds ratios and 95% confidence intervals will be calculated for all analyses. A statistical significance level of 0.05 will be applied. All analyses will be performed using the R programming language.
Phase
N/ASpan
222 weeksSponsor
Aristotle University Of ThessalonikiPleven
Recruiting
Healthy Volunteers
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
Study design: multicenter, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS or LABA-high dose ICS + LAMA containing treatment in asthmatic patients. Dosage regimen and administration Name of the product: Trimbow 172/5/9 micrograms pressurised inhalation, solution. Each delivered dose (the dose leaving the mouthpiece) contains 172 μg of beclometasone dipropionate, 5 μg of formoterol fumarate dihydrate and 9 μg of glycopyrronium (as 11 μg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium (as 12.5 μg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. 1. Aim of the study (research objective) Primary objective: The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT - Asthma Control Test). Primary outcome measures: - Change (improvement) of ACT score, during the 6 months of treatment (Visit 3), compared to the score at baseline. - The percentage of patients achieving an improvement in ACT score of 3 points (MCID, minimum clinically important difference) or more, after the 6-month treatment (Visit 3) compared to baseline. Secondary objectives: Secondary objectives are the assessments of improvement in lung function, adherence to treatment, and health-related quality of life. 2. Test sample and method, recruitment principle No patient recruitment will be performed. Eligible patients will be enrolled during the participating physicians' regular asthma patient management and patients' written informed consent. Patient inclusion will take place among patients having severe asthma at outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patients' visit. The planned number of patients is up to 300. 3. Structure of the study In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all its details, and the patient has read and signed the patient informed consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, smoking history, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values, maintenance and reliever inhaled therapies (former and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L) questionnaire, and adherence to therapy based on Test of Adherence to Inhalers (TAI-12) questionnaire are recorded (data to be recorded in e-CRF). Patients will then attend two additional visits - Visit 2 - 1 month (30 ± 5 days) and Visit 3 - 6 months ± 10 days after enrolment as per routine clinical practice. During these visits, data will be collected, according to routine clinical practice. If the patient's maintenance therapy changes during the study as decided by the treating physician, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The therapy modification and its exact date must be recorded in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately in the eCRF platform in accordance with the respective section of the protocol. This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma. 4. Start and duration of the study The enrolment of the patients can start only after the approval of the Bulgarian Drug Agency and Ethics Committee for Clinical Trials. The study is planned to start at the end of January 2025. Each site will have 3 months to enroll patients. Following the completion of patient enrolment, each patient will be followed up for 6 months. After the visit of the last patient, sites will have one month to collect all missing data/correct any data flagged as erroneous during monitoring. The last patient last visit is expected to take place in October/November 2025, and the study is planned to be concluded in March/April 2026. Secondary objectives are the assessments of improvement in lung function, adherence
 to treatment, and health-related quality of life.
 
 2. Test sample and method, recruitment principle No patient recruitment will be
 performed. Eligible patients will be enrolled during the participating physicians'
 regular asthma patient management and patients' written informed consent. Patient
 inclusion will take place among patients having severe asthma at outpatient clinics
 (the chosen study sites are attached as annexes to the study protocol), strictly at
 the time of the patients' visit. The planned number of patients is up to 300.
 
 3. Structure of the study In accordance with the requirements of non-interventional
 studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be
 made independently of the study. Patient enrolment can take place after the patient
 has been fully informed about the purpose of the study and all its details, and the
 patient has read and signed the patient informed consent form, including any
 questions they may have. Once this has taken place, the data that would have been
 generated anyway during the outpatient examination of the patient in accordance with
 daily practice can be recorded. This is considered the first visit of the study
 (Visit 1). During this visit, the patient's main demographic data, information on
 comorbidities and concomitant medications, smoking history, previous and current
 asthma therapies, asthma specific assessment (including ACT), exacerbation history,
 post-dose lung function values, maintenance and reliever inhaled therapies (former
 and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L)
 questionnaire, and adherence to therapy based on Test of Adherence to Inhalers
 (TAI-12) questionnaire are recorded (data to be recorded in e-CRF). Patients will
 then attend two additional visits - Visit 2 - 1 month (30 ± 5 days) and Visit 3 - 6
 months ± 10 days after enrolment as per routine clinical practice. During these
 visits, data will be collected, according to routine clinical practice. If the
 patient's maintenance therapy changes during the study as decided by the treating
 physician, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the
 patient will be automatically excluded from this NIS. The therapy modification and
 its exact date must be recorded in the eCRF (electronic Case Report Form) of the
 next visit. If the change in therapy is related to a suspected adverse reaction, it
 should be reported separately in the eCRF platform in accordance with the respective
 section of the protocol.
 
 This NIS is open to all eligible patients according to the inclusion and exclusion
 criteria. Permitted concomitant treatments: allowed all medications according to
 local clinical practice (any non-inhalation therapy for asthma or other diseases)
 and reliever (short-acting bronchodilators) inhaled therapies for asthma.
 
 4. Start and duration of the study The enrolment of the patients can start only after
 the approval of the Bulgarian Drug Agency and Ethics Committee for Clinical Trials.
 The study is planned to start at the end of January 2025. Each site will have 3
 months to enroll patients. Following the completion of patient enrolment, each
 patient will be followed up for 6 months. After the visit of the last patient, sites
 will have one month to collect all missing data/correct any data flagged as
 erroneous during monitoring. The last patient last visit is expected to take place
 in October/November 2025, and the study is planned to be concluded in March/April
 2026.
 
 5. Study plan A total of 3 visits will be performed for the assessment of the primary and secondary endpoints during the study. Patients may be enrolled in the study and their data may be recorded, only if this data is recorded in accordance with standard medical practice. - Visit 1: time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected. - Visit 2: 1 month after enrolment (30 days ± 5 days after Visit 1) - Visit 3: 6 months after enrolment (± 10 days).
Phase
N/ASpan
41 weeksSponsor
Chiesi BulgariaPleven
Recruiting
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Phase
3Span
152 weeksSponsor
TakedaPleven
Recruiting
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications. By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.
Phase
N/ASpan
61 weeksSponsor
Neopharm Bulgaria Ltd.Pleven
Recruiting
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: - Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks - Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks - Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Phase
2Span
111 weeksSponsor
Tectonic TherapeuticPleven
Recruiting
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Phase
3Span
101 weeksSponsor
Alumis IncPleven
Recruiting
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo
Phase
3Span
192 weeksSponsor
PfizerPleven
Recruiting