protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04761133 | 2.1.4 | Consenting and co-enrollment | In the TwiC design patients are consented to take part in the cohort study with the possibility of being randomized in the future into trials without being specifically told if a given eligible participant is randomized into a control arm of a trial[5] .
The consenting process for PICS will involve obtaining consent f... | [] |
NCT04761133 | 2.1.5 | Study assessments | PICS is a strictly observational study and all data gathered will be related to the patient's clinical care. The following data will be collected:
- Average age and gender proportion of patients admitted (from screening log)
- Comorbidities
- RAPID score
- Baseline blood tests and follow up inpatient tests(minimum ure... | [] |
NCT04761133 | 2.1.6 | Outcomes | - Examining the incidence of pleural infection admissions locally, the demographics of this cohort and range of medical treatments offered.
- Correlating inpatient outcomes with baseline clinical, biochemical, microbiological and radiological parameters
- Percent of eligible patients randomized to interventional trial... | [
"'Antiseptic irrigation for patients with pleural infection' sub-study"
] |
NCT04761133 | 2.2.1 | Rationale and design | The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis[6]. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema[7] and has been described in the acute management of paediatric pleural infection[8] .
This sub-study will investigate ... | [] |
NCT04761133 | 2.2.2 | Additional eligibility criteria | - Inclusion criteria:
- Unilocular pleural collection
- Exclusion criteria:
- Known or suspected thyroid disease
- Allergy to iodine
- Persistent large collection on follow up imaging 24-48 of post tube insertion that is deemed to require another drainage procedure | [] |
NCT04761133 | 2.2.3 | Specific assessments | - Two applications of 100-250 ml solution of 2% povidone-iodine will be irrigated into the pleural space of eligible patients 12 hours apart. The tube will be clamped for 15 minutes after irrigation and the patient will be asked to change position frequently during this period. The first dose will be applied 24-72 hour... | [] |
NCT04761133 | 2.2.4 | Outcomes | - Safety: incidence of adverse events (new chest pain, fever, dyspnoea or desaturtion) within 24 hours from the first irrigation
- Efficacy
- Time to defervescence
- Time to chest tube removal
- Length of hospital stay
- Need for additional aspiration/tubes
\_ Failure of medical treatment | [] |
NCT04761133 | 3.0 | Data management | A screening log will be kept electronically on a spreadsheet that is password protected on a secure computer. This log will have the name and demographics of potential participants approached for the study. Separate study numbers for PICS and the interventional trial(s) will be assigned and in case of non-enrolment to ... | [] |
NCT04761133 | 4.0 | Statistics | Continuous variables will be compared between the study arms using t-test or Mann Whitney test according to the normality of the study data. Categorical variables (including primary outcome measure) will be compared using the Chi squared test or Fisher exact test as appropriate. | [] |
NCT04761133 | 5.0 | References | - 1. Davies HE, Davies RJO, Davies CWH, on behalf of the BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society pleural disease guideline 2010. Thorax 2010;65(Suppl 2):ii41–53.
- 2. Corcoran JP, Psallidas I, Gerry S, Piccolo F, Koegelenberg CF, Saba T, et al. Prospectiv... | [] |
NCT05079789 | 1 | Introduction | The nephrotic syndrome is characterized by a high ("nephrotic") proteinuria> 3.5 g / day with resulting hypoalbuminemia, as well as by edema and hyperlipidemia. Affected patients suffer from massive generalized edema involving the face and eyelids, effusions into the body cavities pleura, peritoneum and rarely pericard... | [] |
NCT05079789 | 1.1 | Trial Rationale / Justification | Treatment of resistant edema and overhydration in nephrotic syndrome can be challenging and we successfully use ENaC inhibitors (in combination with hydrochlorothiazide) in these patients. However, most clinicians treat nephrotic edema with higher doses of loop diuretics, or combination therapy with thiazide diuretics.... | [] |
NCT05079789 | 1.2 | Benefit / Risk Assessment | Overhydration and edema are serious symptoms that affect patients with nephrotic syndrome. Establishment of a more effective treatment of edema with adding ENaC inhibitors to standard treatment in human nephrotic syndrome has the potential to improve the clinical outcome of patients suffering from sodium retention. Kno... | [] |
NCT05079789 | 1.3 | Advisory Committes | A Data and Safety Monitoring Board and a Scientific Advisory Board are not forseen for this small scale exploratory study. | [] |
NCT05079789 | 2 | Study Objectives | [] | |
NCT05079789 | 2.1 | Primary Objective and Endpoint | In the light of our current results on ENaC activation by serine proteases aberrantly filtered into urine in nephrotic syndrome, we hypothesize that targeting ENaC with amiloride will lead to a more effective reduction of overhydration in nephrotic syndrome than standard treatment with the loop diuretic furosemide.
Pr... | [] |
NCT05079789 | 2.2 | Secondary Objectives and Endpoints | Secondary endpoints represent further parameters to evaluate course of overhydration and regulation of body volume status after initiation of study medication with amiloride or furosemide. Secondary endpoints include
- 1. decrease of OH after 16 days, measured using bioimpedance spectroscopy and expressed as % ECW
- 2... | [] |
NCT05079789 | 3 | Study Design | The study design is a phase IIIb, monocenter, interventional, two-arm, randomized, openlabel controlled clinical trial. We decided for a study type with randomization as method against bias and have omitted blinding, as laboratory results required for safety reasons and dose adjustments will inevitably reveal to which ... | [] |
NCT05079789 | 3.1 | Study Duration and Schedule | The duration of the trial for each subject is 16 days of study treatment and 7 days of follow up.
The overall duration of the trial is expected to be approximately 3.0 years including preparatory and analysis / report phase. Recruitment of subjects is planned to start in 06/2020. The actual overall duration or recruit... | [] |
NCT05079789 | 3.2 | End of Study | The end of the study is defined as the date of the last study visit of the last patient in the trial. Last patient last visit (LPLV) is either the date of the last visit of the last patient to complete the study, or the date at which the last data point from the last patient, which was required for statistical analysis... | [] |
NCT05079789 | 4 | Study Population | This study will include patients with acute nephrotic syndrome (definition see below) due to different underlying diseases (e.g. diabetic nephropathy, membranous nephropathy, minimal change disease, focal segmental glomerulosclerosis). The patients will be recruited from the nephrological outpatient department of the U... | [] |
NCT05079789 | 4.1 | General Criteria for Subject Selection | Adult male and female patients with acute nephrotic syndrome and fulfilling the below outlined inclusion criteria will be enrolled into the study.
Trial population will consist of both genders. Gender distribution in the trial is supposed to reflect the distribution in the real patient's population, i.e. there will be... | [] |
NCT05079789 | 4.1.1 | Inclusion Criteria | *4.1.1. Inclusion Criteria*
Subjects meeting all of the following criteria will be considered for admission to the trial:
- 1. Acute nephrotic syndrome with proteinuria > 3 g/day and formation of edema.
- 2. Age ≥ 18 years at the time of signing the informed consent.
- 3. Understand and voluntarily sign an informed c... | [] |
NCT05079789 | 4.1.2 | Exclusion Criteria | *4.1.2. Exclusion Criteria*
Subjects presenting with any of the following criteria will not be included in the trial:
- 1. Severe reduction of kidney function: Creatinine clearance or calculated GFR 4.8 mmol/l.
- 6. Hypokalemia, plasma potassium concentration 2.0 mmol/l or total albumin corrected calcium > 3.0 mmol... | [] |
NCT05079789 | 5 | Requirements for Trial Site and Investigator | The necessary equipment, including Body Composition Monitor, is permanent available at the trial site.
There are no special training measures required to use the investigational medical product or comparator. | [] |
NCT05079789 | 6 | General Information on the Study Medication | Investigational medicinal product: Amiloride 5 mg
[Registered](http://dict.leo.org/#/search=registered&searchLoc=0&resultOrder=basic&multiwordShowSingle=on) [trade](http://dict.leo.org/#/search=trade&searchLoc=0&resultOrder=basic&multiwordShowSingle=on) [name:](http://dict.leo.org/#/search=name&searchLoc=0&resultOrder... | [
"Comparator: Furosemide 40 mg",
"Co-medication: Hydrochlorothiazide (HCT) 12.5 mg"
] |
NCT05079789 | 6.1 | Manufacturing of the Study Medication | Study medication (investigational medical product amiloride, comparator furosemide and comedication hydrochlorothiazide) is commercially available and will be obtained via the Pharmacy of the University Hosptial Tuebingen directly from the respective manufacturer and used for the study without further manufacturing pro... | [] |
NCT05079789 | 6.2 | Labeling of the Study Medication | The trial medication furosemide and HCT will be provided by the pharmacy of the University Hospital Tuebingen as part of standard therapy medication from German manufacturers. As the trial is not blinded, no additional labelling has to be performed for furosemide and HCT.
The trial medication amiloride will be importe... | [] |
NCT05079789 | 6.3 | Storage of the Medical Product | All trial medication must be kept in a locked area with access restricted to designated trial staff. Amiloride and Furosemide must be stored below 25 °C. Otherwise, no trial medication requires any specific storage conditions according to the manufacturers' instructions. | [] |
NCT05079789 | 6.4 | Drug Accountability, Therapy Compliance and Disposal | The site investigator will keep an account of the trial medication and acknowledge the receipt of all shipments of the trial medication.
Trial medication will be dispensed to the subjects by the investigator at day 0 of study participation. The investigator will document the date of dispensary, subject identification,... | [] |
NCT05079789 | 6.5 | Method of Treatment Assignment | See Section 7.1.4 (Randomisation). | [] |
NCT05079789 | 6.6 | Dose Schedule | Participating patients will take the study medication orally once daily in the morning in fasting state, unchewed with adequate amount of fluid. Initial dose will be amiloride 5 mg or furosemide 40 mg. Initial dose of amilorde was chosen by virtue of clinical expertise and former study results from studies using amilor... | [] |
NCT05079789 | 6.6.1 | Dose Modification | *6.6.1. Dose Modification*
The following considerations were taken into account when determining the dose adjustments:
- The initial dosages determined on the basis of clinical experience and common clinical practice are amiloride 5 mg and furosemide 40 mg. In the treatment of overhydration in nephrotic syndrome with... | [
"Dose adjustment at day 2:",
"Dose adjustment at day 5:",
"Dose adjustment at day 8:",
"Dose adjustment at day 12:",
"Increase is defined as",
"Decrease is defined as"
] |
NCT05079789 | 7 | Study Procedures and Examination Method | This Study will consist of the following consecutive phases: Study entry, Treatment and Follow-up. Time-points and trial procedures are listed in Table 2.
Table 2 Table of Events
| ... | [] |
NCT05079789 | 7.1 | Study Entry | [] | |
NCT05079789 | 7.1.1 | Patient's Informed Consent (see also 11.2.) | *7.1.1. Patient's Informed Consent (see also 11.2.)*
The patient is to be informed both in writing and verbally by the investigator before any studyspecific procedure is performed. Each patient will be informed about the modalities of the clinical study in accordance with the provided patient information. The patient ... | [] |
NCT05079789 | 7.1.2 | Enrollment | *7.1.2. Enrollment*
After the patient's informed consent, a unique subject number for identification purposes will be assigned to the patient in order to maintain his/her pseudonymity. The subject number will be used for the patient throughout the study (= ID number). Screening failures will also be assigned to a subj... | [] |
NCT05079789 | 7.1.3 | Screening | *7.1.3. Screening*
Screening will be performed within 3 days prior to first administration of study medication. After having signed the informed consent, patients will undergo all assessments listed below:
- Anamnesis including medical history and pre-existing medication
- Questions about participation in other clini... | [] |
NCT05079789 | 7.1.4 | Randomisation | *7.1.4. Randomisation*
The randomization will follow a randomization scheme of a 1:1 (amiloride and furosemide). Subjects will be assigned to their respective treatment by randomization. A randomisation number will be assigned (= Random. number). Subjects will then receive their study medication during their personal ... | [] |
NCT05079789 | 7.1.5 | Concomitant Medication and Treatments | *7.1.5. Concomitant Medication and Treatments*
Relevant additional medications and treatments administered to the subjects on entry to the trial or at any time during the trial are regarded as concomitant medications and treatments and must be documented on the appropriate pages of the CRF. | [] |
NCT05079789 | 7.1.6 | Permitted Prior and Concomitant Medications and Treatments | *7.1.6. Permitted Prior and Concomitant Medications and Treatments*
The following concomitant medications and treatments are permitted during the trial and for 3 days prior to enrolment into the clinical trial:
- Proteinuria lowering medication (ACE inhibitors and Angiotensin II receptor) in a low dose (maximally 8 m... | [] |
NCT05079789 | 7.1.7 | Prohibited Prior and Concomitant Medications and Treatments | *7.1.7. Prohibited Prior and Concomitant Medications and Treatments*
Medication that are contraindicated in association with amilorid, furosemide or HCT as defined in the respective SmPCs have been considered in the Exclusion criteria, this includes in particular potassium sparing diuretics and potassium salts.
Furth... | [] |
NCT05079789 | 7.1.8 | Required Prior and Concomitant Medications and Treatments | *7.1.8. Required Prior and Concomitant Medications and Treatments*
As co-medication according to study protocol, hydrochlorothiazide 12.5 mg to 25 mg in addition to the initial medication with amiloride or furosemide is added at day 8 in case of treatment refractory edema as defined in section 6.6.1. Otherwise, there ... | [] |
NCT05079789 | 7.2 | Treatment Phase | During the treatment phase (day 0 – 15) of this trial, participants will receive either amiloride with an initial dose of 5 mg once daily or furosemide with an initial dose of 40 mg once daily. Dose adjustments will be performed as defined in 6.6.1. Beginning at day 8, participants will receive hydrochlorothiazide (ini... | [] |
NCT05079789 | 7.2.1 | Description of Patients' Visits | *7.2.1. Description of Patients' Visits*
Visit 1 is the screening visit and described in 7.1.3. The patient will be randomized if all inclusion criteria and no exclusion criteria are fulfilled.
The patient wil be instructed to take study medication in the morning on all study days during treatment phase (at day 0 – 1... | [] |
NCT05079789 | 7.3 | Assessment of Efficacy | [] | |
NCT05079789 | 7.3.1 | Efficacy Parameters | *7.3.1. Efficacy Parameters*
Aim of the study is to prove the efficacy of amiloride for reduction of edema and overhydration in human nephrotic syndrome in comparison to standard medication with furosemide. Overhydration as the primary endpoint variable is determined directly using bioimpedance spectrosycopy with the ... | [] |
NCT05079789 | 7.3.2 | Methods and Timing for Assessing, Recording, and Analysing of Efficacy Parameters | *7.3.2. Methods and Timing for Assessing, Recording, and Analysing of Efficacy Parameters*
Body fluid status will be determined using bioimpedance spectroscopy with the device Body Composition Monitor (BCM, Fresenius Medical Care AG & Co). Bioimpedance spectroscopy measures the electrical resistance of the body tissue... | [
"A) Measurement of body fluid status with the Body Composition Monitor:",
"C) Measurement of laboratory parameters:"
] |
NCT05079789 | 7.4 | Assessment of Safety | [] | |
NCT05079789 | 7.4.1 | Safety Parameters | *7.4.1. Safety Parameters*
Safety assessment includes adverse events, concomitant medication and check of study medication. As safety parameters for specific risks of the study, serum potasium and sodium levels and plasma creatinine concentration are monitored during study participation.
| [
"(Serious) Adverse Events (see section 10)"
] |
NCT05079789 | 7.4.2 | Methods and Timing for Assessing, Recording, and Analysing Safety Parameters | *7.4.2. Methods and Timing for Assessing, Recording, and Analysing Safety Parameters*
Check for adverse events is performed continuously from beginning of study medication until 7 days after end of study treatment. Check of concomitant medication is performed at screening visit and continuously until end of follow up.... | [] |
NCT05079789 | 7.5 | Premature termination of clinical trial for a trial subject | Reasons for premature termination of trial for an individual trial subject are:
- 1. Death
- 2. Withdrawal of consent
- 3. Patient lost to follow-up
- 4. Major protocol violation
- 5. At their own request or at request of the legal representative
- 6. If, in the investigator's opinion, continuation of the trial would ... | [] |
NCT05079789 | 7.6 | Premature closure of a trial site | Not applicable since monocentric study. | [] |
NCT05079789 | 7.7 | Premature termination of the trial | The trial may be prematurely terminated, if in the opinion of the sponsor and coordinating investigator there is sufficient reasonable cause. Written notification documenting the reason for study termination will be provided to the investigators.
In case of the following situations, a premature termination of the tria... | [] |
NCT05079789 | 7.8 | End of Study of Subjects | The End of Study for a patient enrolled in this trial is defined as the date of the last visit of the respective patient in the trial. | [] |
NCT05079789 | 7.8.1 | Plan for Treatment or Care after End of Study | *7.8.1. Plan for Treatment or Care after End of Study*
At the end of study tretmant, further medication for nephrotic syndrome will be determined by the nephrologist of the patient's medical practice or the attending physician in the nephrologic outpatient clinic of the University Hospital Tübingen. The study medicati... | [] |
NCT05079789 | 8 | Quality Control and Quality insurance | [] | |
NCT05079789 | 8.1 | Monitoring | Monitoring for this study is provided by the Zentrum für Klinische Studien Tübingen (ZKS Tübingen). The monitoring will be conducted according to ZKS Tübingen's internal SOPs and a dedicated monitoring manual for the study. The monitoring timelines include, for all centres, an initiation visit, regular monitor visits d... | [] |
NCT05079789 | 8.2 | Audits/ Inspections | In addition to the monitoring activities, a comprehensive quality control will be conducted by CI in the form of audits. These may include checking the whole course of the study, the documentation, statistical analysis, the trial centre, the investigators, and the monitor. The competent regulatory authorities may also ... | [] |
NCT05079789 | 8.3 | Documentation: Collection, Handling, Storage and Archiving of Data | [] | |
NCT05079789 | 8.3.1 | Case Report Form | *8.3.1. Case Report Form*
The trial case report form (CRF) is the primary data collection instrument for the trial. All data requested on the CRF must be recorded. All missing data must be explained.
For this project, paper Case Report Forms (CRFs) will be used. The investigator is responsible for ensuring that all s... | [] |
NCT05079789 | 8.3.2 | Source Data | *8.3.2. Source Data*
Source data is all information, original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents. Examples of these original documents and data records include: ho... | [] |
NCT05079789 | 8.3.3 | Data Handling | *8.3.3. Data Handling*
After first check for plausibility by eye, all data will be entered in a database as recorded in the CRF. To ensure data quality a double data entry will be performed.
The trial master file, the CRFs, and other material supplied for the conduct of the study will be retained by Sponsor/CRO accor... | [] |
NCT05079789 | 8.3.4 | Storage and Archiving of Data | *8.3.4. Storage and Archiving of Data*
According to the §13 of the German GCP-Ordinance all important trial documents (e.g. CRF) will be archived for at least 10 years after the trial termination.
The investigator(s) will archive all trial data (source data and Investigator Site File (ISF) including subject identific... | [] |
NCT05079789 | 9 | Statistical Analyses | [] | |
NCT05079789 | 9.1 | Study Population Definition | [] | |
NCT05079789 | 9.1.1 | Sample Size and Power Consideration | *9.1.1. Sample Size and Power Consideration*
Primary endpoint of the study is decrease of overhydration (measured using bioimpedance spectroscopy) after 8 days, compared to baseline. Based on data from a baseline sample (n = 14) and clinical experience on reduction of overhydration baseline overhydration is expected t... | [] |
NCT05079789 | 9.1.2 | Intention-to-Treat Population | *9.1.2. Intention-to-Treat Population*
All statistical analyses will be based on the Intention-to-Treat Population (ITT). The ITT includes all randomised patients with exception of patients who withdraw their informed consent for the analysis of their data during the study. | [] |
NCT05079789 | 9.2 | Analysis of Primary Variable | The primary endpoint variable is change of overhydration (OH) after 8 days compared to baseline, measured by bioimpedance spectroscopy using the Body Composition Monitor and expressed in percent of ectracellular water (% ECW). The primary endpoint variable will be compared between the two study arms, which are patients... | [] |
NCT05079789 | 9.3 | Analysis of Secondary Variables | Secondary endpoint variables are listed in section 2.2. All secondary endpoints will be compared and statistically assessed for descriptive purposes and not in a confirmatory sense. The aim of the analysis is explorative data analysis, not hypothesis testing or generation of evidence for efficacy and no attempt will be... | [] |
NCT05079789 | 9.4 | Safety Analysis | Safety will be assessed by frequency tabulations and line listings. | [] |
NCT05079789 | 9.5 | Descriptive Analysis | Descriptive analyses will include absolute and percentage frequencies for categorical variables, means, medians, standard deviations, quartiles and ranges for quantitative variables and medians, quartiles and ranges for ordinal variables. | [] |
NCT05079789 | 9.6 | Handling of Missing Data | All variables included in the CRF are mandatory. The monitoring will assure quality of the assessments. Thus, missing values are to be expected only due to refusal by patients. In the analysis of the primary endpoint missing values will be imputed using multiple imputation approaches, complete case and last observation... | [] |
NCT05079789 | 9.7 | Subgroup Analysis | No subgroup analysis is planned. | [] |
NCT05079789 | 9.8 | Biometric Report | The statistical analysis will be conducted by the IKEAB, once the database is declared closed. In this study protocol the directions of the planned analyses are given. Before starting the final analysis, a detailed statistical analysis plan (SAP) will be written and signed by the responsible statistician and the coordi... | [
"10.Safety"
] |
NCT05079789 | 10.1 | Definition of Adverse Events and Side Effects | [] | |
NCT05079789 | 10.1.1 | Adverse Events | *10.1.1. Adverse Events*
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal ... | [] |
NCT05079789 | 10.1.2 | Adverse Drug Reaction | *10.1.2. Adverse Drug Reaction*
Adverse reaction means all untoward and unintended responses to an investigational medicinal product unrelated to the dose administered. | [] |
NCT05079789 | 10.1.3 | Unexpected Adverse Drug Reaction | *10.1.3. Unexpected Adverse Drug Reaction*
An unexpected Adverse Drug Reaction (ADR) is a reaction which nature or severity is not consistent with the applicable product information available for the IMP. Expected ADRs are listed in the appropriate reference documents, e.g. Investigator's Brochure; Summary of Product ... | [] |
NCT05079789 | 10.1.4 | Serious Adverse Event and Serous Adverse Reaction | *10.1.4. Serious Adverse Event and Serous Adverse Reaction*
AEs are classified as "non-serious" or "serious".
A serious adverse event (SAE) is one that at any dose:
- Results in death.
- Is life-threatening (the term life-threatening refers to an event in which the subject was at risk of death at the time of event a... | [] |
NCT05079789 | 10.2 | Period of Observation | For the purpose of this trial, the period of observation for collection of adverse events extends from the time the patient starts study medication until 7 days after the last dose administrated.
All adverse events that occur in the course of a clinical trial regardless of the causal relationship must be monitored and... | [] |
NCT05079789 | 10.3 | Documentation and Reporting of Adverse Events | [] | |
NCT05079789 | 10.3.1 | Documentation and Reporting of Adverse Events by the Investigator | *10.3.1. Documentation and Reporting of Adverse Events by the Investigator*
The investigator must document all adverse events that occur during the observation period set in this protocol (see Section 10.2) on the pages provided in the case report form. Additional instructions may be provided in the investigator file ... | [] |
NCT05079789 | 10.3.2 | Assessment of Severity and Causality | *10.3.2. Assessment of Severity and Causality*
The investigator will also provide an assessment of the severity of the event according to CTCAE criteria (Version 5.0) and causal relationship between the event and each of the investigational products or trial procedures.
AEs and SAEs should be evaluated for severity a... | [] |
NCT05079789 | 10.3.3 | Sponsors Assessment of the SAEs | *10.3.3. Sponsors Assessment of the SAEs*
All SAE will be subject to a second assessment by the trial Sponsor or authorized second assessors.
The second assessor will fill out a 'Second Assessment Form' for each SAE containing.
- Event serious yes/no
- Relationship between SAE and IMP
- Expectedness of SAE according... | [] |
NCT05079789 | 10.3.4 | Follow-up of Initial Report | *10.3.4. Follow-up of Initial Report*
Information not available at the time of the initial report (e.g. an end date for the adverse event or laboratory values received after the report) must be documented on a "Serious Adverse Event" form with the box "Follow-up" checked under "Report type".
All patients who have adv... | [] |
NCT05079789 | 10.3.5 | Suspected Unexpected Serious Adverse Reaction (SUSAR) | *10.3.5. Suspected Unexpected Serious Adverse Reaction (SUSAR)*
SAEs have to be assessed by the second assessor wether they are both suspected, i.e. possibly related to IMP and 'unexpected', i.e. the nature and / or severity of which is not consistent with the applicable product information. They are then to be classi... | [] |
NCT05079789 | 10.3.6 | Expedited Reporting to the Regulatory Authorities | *10.3.6. Expedited Reporting to the Regulatory Authorities*
The competent authority and the ethics committee responsible must be informed by the Sponsor/CI of all fatal or life-threatening SUSARs. This must be done immediately, at the latest seven calendar days after becoming aware of the minimum criteria for reportin... | [
"Fatal and life-threatening SUSARs",
"SUSARs that are not fatal or life threatening"
] |
NCT05079789 | 10.3.7 | Examination and Report of Changes in the Risk to Benefit Ratio | *10.3.7. Examination and Report of Changes in the Risk to Benefit Ratio*
Without delay, and at the latest within 15 days of the decision for the need to do so, the Sponsor / CI will inform the competent authority, the ethics committee responsible of any events or factors that could result in a review of the risk-benef... | [] |
NCT05079789 | 10.3.8 | Report to the Investigator | *10.3.8. Report to the Investigator*
The Sponsor / CI will inform investigators of all SUSARs including all relevant further information within the periods set by the authority.
If new information becomes known that is different from the scientific information given to the investigator, all investigators will be info... | [] |
NCT05079789 | 10.4 | Annual Safety Report | Once a year, the Sponsor / CI will supply a report on the safety of trial subjects with all available relevant information concerning patient safety during the reference period to the competent authorities. This report will also be supplied to the responsible ethics committee. The annual safety report will be compiled ... | [] |
NCT05079789 | 10.5 | Deviations from the protocol | Any deviation from the protocol will be noted in the CRF. The PI or a nominated person will evaluate this deviation from the protocol and will decide on the further course of the trial for the respective subject. | [] |
NCT05079789 | 10.6 | Reporting of pregnancy | Pregnancies and suspected pregnancies (including a positive pregnancy test regardless of age or disease state) of a female patient or the female partner of a male patient occurring while the patient is on study drug or within 28 days of the patient's last dose of study drug are considered events to be reported immediat... | [
"11.Regulatory Consideration"
] |
NCT05079789 | 11.1 | Ethical Conduct of Clinical Study | [] | |
NCT05079789 | 11.1.1 | Good Clinical Practice, Declaration of Helsinki and legal Provision | *11.1.1. Good Clinical Practice, Declaration of Helsinki and legal Provision*
The procedures set out in this trial protocol, pertaining to the conduct, evaluation, and documentation of this trial, are designed to ensure that all persons involved in the trial act according to Good Clinical Practice (GCP) and the ethica... | [] |
NCT05079789 | 11.2 | Subject Information and Informed Consent | Each patient will be informed about the modalities of the clinical study in accordance with the provided patient informed consent (IC). The patient is to be informed both in writing and verbally by the investigator before any study-specific procedure is performed. The patient must be given sufficient time (i.e. >24 h) ... | [] |
NCT05079789 | 11.3 | Insurance | Each patient is insured against any health impairment occurring as a result of participation in the study in accordance with the laws and regulations of the Deutsches Arzneimittelgesetz. The insurance is covered by HDI-Gerling Industrie Versicherung AG, Am Schönenkamp 45, 40599 Düsseldorf, phone +49 211 177 69 0, fax +... | [] |
NCT05079789 | 11.4 | Confidentiality | The data obtained in the course of the trial will be treated according to the European General Data Protection Regulation (Datenschutz-Grundverordnung; DSGVO) and the applicable local data protection regulations as well as the AMG. The details on confidentiality according to EU-DSGVO and AMG are provided in the patient... | [] |
NCT05079789 | 11.5 | Responsibility of the the Investigator | The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, any amendments to the protocol, the trial treatments, and their trial-related duties and functions.
The investigator should maintain a list of subinvestigators and other appropriately qualified persons ... | [] |
NCT05079789 | 11.6 | Registration of the Trial | Prior to the beginning of the clinical phase (First Patient In) the Sponsor / CI will register the trial in http://www.clinicaltrials.gov. The trial has be given a unique EudraCT number. | [] |
Subsets and Splits
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