Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency (IDA-II)

January 12, 2026 updated by: Prof. Dr. Frank Behrens

Safety and Efficacy of Postoperative i.v. Iron Substitution With Polyglucoferron Compared to Ferric Carboxymaltose and Oral Iron in Patients With Diagnosed Iron Deficiency Who Develop Anaemia Peri- or Postoperatively (IDA II)

Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, patients with confirmed and documented preoperative non-anaemic iron deficiency (diagnosis up to 28 days before surgery in routine pre-surgery monitoring) who develop anaemia within 12 to 72 hours after start of surgery (with additional confirmation at Baseline) and for whom fast replenishment of iron stores is necessary, will be included and substituted within 24h after Screening Visit/V1. Peri- or postoperative anaemia will be assessed as soon as possible but earliest 12 h after surgery. For short term safety analysis iron in urine will be measured in the first urine after the end of i.v. administration in the first 35 patients who are eligible for analysis in each i.v. treatment group. Only those patients are eligible for whom haematuria and/or proteinuria are excluded using dip stick test. The Ferric Carboxymaltose treatment arm will be closed if a sufficient number of patients is included for safety analysis.The study will then be continued for assessment of co-primary efficacy endpoint: The effectiveness of postoperative i.v. iron substitution with Polyglucoferron compared to conventional oral iron substitution with Ferrous sulfate (treatment 28 - 35 days) to normalize Hb-values or to increase Hb-values by at least 1.5 g/dl until visit 4 will be evaluated as well as patient related outcomes, such as the decreased need for allogenic blood transfusions. In addition, the well-being of the patient will be assumed to improve after treatment using the SF36 questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Hessia
      • Frankfurt, Hessia, Germany, 60590
        • Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or female; aged ≥ 18 years
  • Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline
  • Confirmed and documented preoperative iron deficiency defined as S-ferritin <100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery
  • need for fast iron replenishment as judged by the treating physician
  • Written informed consent; willing/able to comply with the protocol

Exclusion Criteria:

  • Pregnancy in female patients or breastfeeding women
  • Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
  • Severe physical inability, e.g., American society of anesthesiologists (ASA) physical status IV or V
  • Patients receiving blood transfusion 24 week prior surgery
  • Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
  • Anticipated medical need for erythropoiesis-stimulating agents during the main study period
  • Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed determined either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care)

  • Patients with any contraindication to the investigational products, e.g.,

    1. known sensitivity to iron or an ingredient of the investigational products
    2. Significant history of systemic allergic reactions
    3. Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
    4. Acute or chronic intoxication
    5. Infection (patient on non-prophylactic antibiotics)
    6. Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
  • Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min
  • Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease
  • Primary haematologic disease
  • Drug or alcohol abuse according to WHO definition
  • Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
  • Current or previous participation in another clinical trial during the last 90 days before screening

  • Exclusion criteria related to Ferrous sulfate

    1. according to Summary of product characteristics (SmPC)
    2. hypersensitivity to any ingredient in the formulation
    3. concomitant parenteral iron
    4. haemochromatosis, and other iron overload syndromes

  • Exclusion criteria related to Ferric Carboxymaltose:

    1. according to Summary of product characteristics (SmPC)
    2. hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients
    3. known serious hypersensitivity to other parenteral iron products
    4. anaemia not attributed to iron deficiency
    5. evidence of iron overload or disturbances in the utilisation of iron

  • Exclusion criteria related to Polyglucoferron

    1. hypersensitivity to any ingredient in the formulation
    2. known serious hypersensitivity to other parenteral iron products
    3. anaemia not attributed to iron deficiency
    4. evidence of iron overload or disturbances in the utilisation of iron

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Polyglucoferron
once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg
Drug: Polyglucoferron
intravenous administration
Other Names:
  • Feramyl
Active Comparator: Ferric Carboxymaltose
Once intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max. single dose of 1000 mg)
Drug: Ferric carboxymaltose
intravenous administration
Other Names:
  • Ferinject
Active Comparator: Ferrous sulfate
capsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days
Drug: Ferrous Sulfate
oral administration
Other Names:
  • Ferro sanol duodenal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl
Time Frame: Baseline to approximately 30 days post-baseline (visit 4)
Proportion of patients in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to Baseline (BL)
Baseline to approximately 30 days post-baseline (visit 4)
pre post difference of volumen-corrected urine iron levels
Time Frame: urine sampled prior to administration and approximately 1 to 8 hours post-baseline
Pre-post difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, defined as short term safety surrogate marker after administration of the i.v. treatments, compared between Polyglucoferron and Ferric Carboxymaltose (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine).
urine sampled prior to administration and approximately 1 to 8 hours post-baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with normalization of Hemoglobin (Hb) at visit 4
Time Frame: 30 days after baseline (Visit 4)
measurement of normalization of Hb defined in World Health Organization (WHO) classification
30 days after baseline (Visit 4)
Level of Hb until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
determination of levels of Hemoglobin (Hb) (comparison to baseline)
Baseline to 30 days after baseline (visit 4)
Level of Transferrin Saturation (TSAT) until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
determination of levels of Transferrin Saturation (TSAT) (mean values in comparison to baseline)
Baseline to 30 days after baseline (visit 4)
Level of serum-iron until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
determination of levels of serum-iron (mean values in comparison to baseline)
Baseline to 30 days after baseline (visit 4)
Level of serum-transferrin until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
determination of levels of serum-transferrin (mean values in comparison to baseline)
Baseline to 30 days after baseline (visit 4)
Level of serum-ferritin until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
determination of levels of serum-ferritin (mean values in comparison to baseline)
Baseline to 30 days after baseline (visit 4)
Value of serum-phosphate levels at visit 4 (i.v. groups only)
Time Frame: baseline and 30 days after baseline (visit 4)
measurement of serum-phosphate levels (mean values in comparison to baseline)
baseline and 30 days after baseline (visit 4)
Overall tolerability and number, incidence, seriousness, severity, relationship of Adverse Events (AE) and serious adverse events (SAE) until 30 days after Investigational medicinal product (IMP) administration
Time Frame: baseline to 30 days after last IMP administration
determination of number, incidence, seriousness, severity and causality of adverse events and serious adverse events
baseline to 30 days after last IMP administration
Level of c-reactive protein on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of C reactive protein (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of ALT on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of ALT (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of AST on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of AST (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of gamma-glutamyltransferase on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of gamma-glutamyltransferase (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of urea nitrogen on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of urea nitrogen (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of serum creatinine on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of serum creatinine (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of white blood cells on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of white blood cells (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Values of thrombocytes on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of values of thrombocytes (description of changes in values in comparison to baseline)
baseline to 30 days after baseline (visit 4)
Changes in systolic blood pressure on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of vital signs as systolic blood pressure
baseline to 30 days after baseline (visit 4)
Changes in body temperature on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of body temperature
baseline to 30 days after baseline (visit 4)
Changes in pulse rate on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of pulse rate
baseline to 30 days after baseline (visit 4)
Changes in diastolic blood pressure on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of vital signs as diastolic blood pressure
baseline to 30 days after baseline (visit 4)
Assessment of general conditions on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of general condition will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of Skin on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of Skin will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of eyes on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of eyes will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of ears on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of ears will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of mouth on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of mouth will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of nose on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of nose will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of throat on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of throat will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of cardiovascular system on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of cardiovascular system will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of respiratory system on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of respiratory system,will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of abdomen on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of abdomen will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of gastrointestinal tract on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of gastrointestinal tract will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
clinical assessments of kidneys on each available visit
Time Frame: baseline to 30 days after baseline (visit 4)
Documentation of clinical assessments of kidneys will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
baseline to 30 days after baseline (visit 4)
AEs related to injection/ infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
Time Frame: baseline to 30 days after last IMP administration
Documentation of numbers of adverse events related to injection/infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
baseline to 30 days after last IMP administration
Number of deaths from any cause until visit 4
Time Frame: baseline to 30 days after baseline (visit 4)
documentation of number of deaths
baseline to 30 days after baseline (visit 4)
Proportion of units of allogenic red blood cell transfusion from BL until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
Documentation of number of units of allogenic red blood cell transfusion
Baseline to 30 days after baseline (visit 4)
Proportion of patients with need of allogenic red blood cell transfusion from BL until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
Documentation of the use of allogenic red blood cell transfusion
Baseline to 30 days after baseline (visit 4)
treatment effect on change in Quality of Life (SF36) at visit 4 compared to BL
Time Frame: Baseline to 30 days after baseline (visit 4)
documentation of quality of life in the Short Form Health Survey (SF36) with 36 items relying upon patient self-reporting. It contains eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Baseline to 30 days after baseline (visit 4)
Duration of hospital stay (days) until visit 4
Time Frame: Baseline to 30 days after baseline (visit 4)
documentation of days in hospital
Baseline to 30 days after baseline (visit 4)
Level ofl iron in plasma after end of iron administration (for the i.v. groups (safety analysis group) only)
Time Frame: time points directly after administration of intravenous (i.v.) treatment (approximately 15 minutes post-baseline)
measurement of iron level in plasma
time points directly after administration of intravenous (i.v.) treatment (approximately 15 minutes post-baseline)
Level of iron in plasma after urine sampling (for the i.v. groups (safety analysis group) only)
Time Frame: time points after urine sampling (approximately 1 to 8 hours post-baseline)
measurement of iron level in plasma
time points after urine sampling (approximately 1 to 8 hours post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Frank Behrens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Frankfurt, Department of Anaesthesiology
IRON4U
University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Meybohm, MD, University Hospital of Goethe-University Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMP0916_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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