ClinicalTrials.gg
Sign In
CompletedNCT03282955HOMEUpdated Jul 4, 2025Results posted

The HOME Study (HPN With OMEGA-3)

A Phase 4 interventional study of Lipidem and Lipofundin MCT 20% in Patients Requiring Home Parenteral Nutrition, sponsored by B. Braun Melsungen AG. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by B. Braun Melsungen AG · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

02

Conditions studied

  • Patients Requiring Home Parenteral Nutrition
03

In context

Lead sponsor

B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Browse B. Braun studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed available
  • Male or female patients ≥ 18 years of age
  • Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months
  • Patients receiving ≥ 3.0 g lipids/kg body weight per week

Exclusion criteria

Exclusion:

  • Persistent high total values in medical history of last 6 months (> 40µmol/l)
  • Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
  • Patients with history of cancer and anti-cancer treatment within the last 2 years
  • to egg, fish, peanut or soya-bean protein or to any of the active substances or
  • Patients treated in the past or currently with Teduglutide

  • to products (if available from medical records) including:

    • Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l)
    • Severe coagulopathy
    • Intrahepatic cholestasis
    • Severe hepatic insufficiency
    • Severe renal insufficiency in absence of renal replacement therapy
    • Acute thromboembolic events
    • Fat embolism
    • Aggravating haemorrhagic diatheses
    • Metabolic acidosis

  • General contraindications to parenteral nutrition (if available from medical records) including:

    • Unstable circulatory status with vital threat (states of collapse and shock)
    • Acute phase of cardiac infarction or stroke
    • Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin)
    • Inadequate cellular oxygen supply
    • Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration)
    • Acute pulmonary edema
    • Decompensated cardiac insufficiency
  • Positive test for , or C (from medical history)
  • Known or suspected drug or alcohol abuse
  • Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
  • Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
  • Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation For women with (i.e. females who are not chemically or surgically sterile or females who are not )
  • Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
  • Lactation
  • Women of childbearing potential who do not agree to apply adequate
  • Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Lipidem

    i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)

    Drug: Lipidem

  • Active comparator
    Lipofundin MCT

    i.v. lipid emulsion

    Drug: Lipofundin MCT 20%

Interventions

  • DrugLipidem

    Lipoplus i.v. lipid emulsion for parenteral nutrition

  • DrugLipofundin MCT 20%

    Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

06

What researchers measure

Primary outcomes

  1. Change of Liver Function Parameters From Baseline to Visit 2

    Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.

    Time frame: 8 weeks

Secondary outcomes

  1. Bilirubin

    Change from baseline

    Time frame: 8 weeks

  2. Alanine Transaminase (ALT)

    Change from baseline

    Time frame: 8 weeks

  3. Aspartate Transaminase (AST)

    Change from baseline

    Time frame: 8 weeks

  4. AST/ALT Ratio

    Change from baseline

    Time frame: 8 weeks

  5. Alkaline Phosphatase (ALP)

    Change from baseline

    Time frame: 8 weeks

  6. Gamma-glutamyl Transpeptidase (GGT)

    Change from baseline

    Time frame: 8 weeks

  7. White Blood Cells (WBCs)

    Change from baseline

    Time frame: 8 weeks

  8. Red Blood Cells (RBCs)

    Change from baseline

    Time frame: 8 weeks

  9. Hemoglobin (Hb)

    Change from baseline

    Time frame: 8 weeks

  10. Platelets

    Change from baseline

    Time frame: 8 weeks

  11. International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)

    Change from baseline

    Time frame: 8 weeks

  12. Activated Partial Thromboplastin Time (aPTT)

    Change from baseline

    Time frame: 8 weeks

  13. Hematocrit (Hct)

    Change from baseline

    Time frame: 8 weeks

  14. Blood Glucose

    Change from baseline

    Time frame: 8 weeks

  15. Sodium

    Change from baseline

    Time frame: 8 weeks

  16. Chloride

    Change from baseline

    Time frame: 8 weeks

  17. Potassium

    Change from baseline

    Time frame: 8 weeks

  18. Calcium

    Change from baseline

    Time frame: 8 weeks

  19. Magnesium

    Change from baseline

    Time frame: 8 weeks

  20. Phosphate

    Change from baseline

    Time frame: 8 weeks

  21. Serum Creatinine

    Change from baseline

    Time frame: 8 weeks

  22. Triglycerides

    Change from baseline

    Time frame: 8 weeks

  23. Cholesterol

    Change from baseline

    Time frame: 8 weeks

  24. High-density Lipoprotein (HDL)

    Change from baseline

    Time frame: 8 weeks

  25. Low-density Lipoprotein (LDL)

    Change from baseline

    Time frame: 8 weeks

  26. C-reactive Protein (CRP)

    Change from baseline

    Time frame: 8 weeks

  27. α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)

    Change from baseline

    Time frame: 8 weeks

  28. Triene:Tetraene Ratio in Plasma, Reduction From Baseline

    Derived from fatty acid pattern in plasma

    Time frame: 8 weeks

  29. Adverse Events

    Number of adverse events (including serious adverse events)

    Time frame: 8 weeks

  30. BMI

    Body mass index Change from baseline

    Time frame: 8 weeks

  31. Prothrombin Time (PT)

    Change from baseline

    Time frame: 8 weeks

07

Results

Posted Jul 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneLipidemLipofundin MCT
Started4034
Completed3530
Not completed54

Outcome measures

PrimaryChange of Liver Function Parameters From Baseline to Visit 2

Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.

Time frame:
8 weeks
Reported as:
Mean · normalized sum- no unit
Change of Liver Function Parameters From Baseline to Visit 2
normalized sum- no unitLipidemLipofundin MCT
Change of Liver Function Parameters From Baseline to Visit 20.0606 ± 3.0876-0.0703 ± 1.8063
Statistical analysis
  • Lipidem vs Lipofundin MCT · t-test, 1 sided · p = 0.025
SecondaryBilirubin

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L
Bilirubin
µmol/LLipidemLipofundin MCT
Bilirubin0.36 ± 3.340.04 ± 3.26
SecondaryAlanine Transaminase (ALT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Alanine Transaminase (ALT)
µkat/LLipidemLipofundin MCT
Alanine Transaminase (ALT)0.06 ± 0.600.01 ± 0.25
SecondaryAspartate Transaminase (AST)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Aspartate Transaminase (AST)
µkat/LLipidemLipofundin MCT
Aspartate Transaminase (AST)-0.03 ± 0.38-0.00 ± 0.21
SecondaryAST/ALT Ratio

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · Ratio
AST/ALT Ratio
RatioLipidemLipofundin MCT
AST/ALT Ratio0.53 ± 1.000.89 ± 2.52
SecondaryAlkaline Phosphatase (ALP)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Alkaline Phosphatase (ALP)
µkat/LLipidemLipofundin MCT
Alkaline Phosphatase (ALP)0.13 ± 0.66-0.15 ± 1.46
SecondaryGamma-glutamyl Transpeptidase (GGT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Gamma-glutamyl Transpeptidase (GGT)
µkat/LLipidemLipofundin MCT
Gamma-glutamyl Transpeptidase (GGT)0.02 ± 0.38-0.11 ± 1.64
SecondaryWhite Blood Cells (WBCs)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^9 cells/L
White Blood Cells (WBCs)
10^9 cells/LLipidemLipofundin MCT
White Blood Cells (WBCs)0.45 ± 1.420.19 ± 1.39
SecondaryRed Blood Cells (RBCs)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^12 cells/L
Red Blood Cells (RBCs)
10^12 cells/LLipidemLipofundin MCT
Red Blood Cells (RBCs)-0.02 ± 0.28-0.10 ± 0.28
SecondaryHemoglobin (Hb)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · g/L
Hemoglobin (Hb)
g/LLipidemLipofundin MCT
Hemoglobin (Hb)0.52 ± 8.82-1.75 ± 8.22
SecondaryPlatelets

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^9 cells/L
Platelets
10^9 cells/LLipidemLipofundin MCT
Platelets3.06 ± 41.116.90 ± 50.33
SecondaryInternational Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · Ratio
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)
RatioLipidemLipofundin MCT
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)-0.01 ± 0.25-0.16 ± 0.71
SecondaryActivated Partial Thromboplastin Time (aPTT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · seconds
Activated Partial Thromboplastin Time (aPTT)
secondsLipidemLipofundin MCT
Activated Partial Thromboplastin Time (aPTT)0.02 ± 3.850.97 ± 7.69
SecondaryHematocrit (Hct)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · L/L
Hematocrit (Hct)
L/LLipidemLipofundin MCT
Hematocrit (Hct)-0.00 ± 0.03-0.01 ± 0.03
SecondaryBlood Glucose

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Blood Glucose
mmol/LLipidemLipofundin MCT
Blood Glucose0.43 ± 0.94-0.14 ± 1.33
SecondarySodium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Sodium
mmol/LLipidemLipofundin MCT
Sodium0.18 ± 2.67-0.58 ± 2.74
SecondaryChloride

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Chloride
mmol/LLipidemLipofundin MCT
Chloride-0.19 ± 3.33-0.15 ± 4.08
SecondaryPotassium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Potassium
mmol/LLipidemLipofundin MCT
Potassium0.06 ± 0.370.01 ± 0.46
SecondaryCalcium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Calcium
mmol/LLipidemLipofundin MCT
Calcium-0.01 ± 0.15-0.01 ± 0.10
SecondaryMagnesium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Magnesium
mmol/LLipidemLipofundin MCT
Magnesium0.00 ± 0.09-0.00 ± 0.06
SecondaryPhosphate

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Phosphate
mmol/LLipidemLipofundin MCT
Phosphate-0.02 ± 0.18-0.00 ± 0.16
SecondarySerum Creatinine

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L
Serum Creatinine
µmol/LLipidemLipofundin MCT
Serum Creatinine3.87 ± 32.420.43 ± 9.23
SecondaryTriglycerides

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Triglycerides
mmol/LLipidemLipofundin MCT
Triglycerides0.10 ± 0.550.19 ± 0.68
SecondaryCholesterol

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Cholesterol
mmol/LLipidemLipofundin MCT
Cholesterol0.01 ± 0.390.02 ± 0.71
SecondaryHigh-density Lipoprotein (HDL)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
High-density Lipoprotein (HDL)
mmol/LLipidemLipofundin MCT
High-density Lipoprotein (HDL)-0.12 ± 0.190.03 ± 0.23
SecondaryLow-density Lipoprotein (LDL)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Low-density Lipoprotein (LDL)
mmol/LLipidemLipofundin MCT
Low-density Lipoprotein (LDL)0.07 ± 0.33-0.08 ± 0.76
SecondaryC-reactive Protein (CRP)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · nmol/L
C-reactive Protein (CRP)
nmol/LLipidemLipofundin MCT
C-reactive Protein (CRP)37.16 ± 160.03-24.65 ± 209.18
Secondaryα-Tocopherol/Vitamin E (Facultative if Routinely Assessed)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L]
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)
µmol/L]LipidemLipofundin MCT
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)-3.00 ± 6.60-1.94 ± 10.99
SecondaryTriene:Tetraene Ratio in Plasma, Reduction From Baseline

Derived from fatty acid pattern in plasma

Time frame:
8 weeks
Reported as:
Mean · Ratio
Triene:Tetraene Ratio in Plasma, Reduction From Baseline
RatioLipidemLipofundin MCT
Triene:Tetraene Ratio in Plasma, Reduction From Baseline0.011 ± 0.0240.008 ± 0.028
SecondaryAdverse Events

Number of adverse events (including serious adverse events)

Time frame:
8 weeks
Reported as:
Number · Adverse events
Adverse Events
Adverse eventsLipidemLipofundin MCT
Adverse Events3125
SecondaryBMI

Body mass index Change from baseline

Time frame:
8 weeks
Reported as:
Mean · kg/m^2
BMI
kg/m^2LipidemLipofundin MCT
BMI0.4 ± 0.70.2 ± 0.7
SecondaryProthrombin Time (PT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · s
Prothrombin Time (PT)
sLipidemLipofundin MCT
Prothrombin Time (PT)-0.8 ± 1.151.27 ± 5.16

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lipidem0/40 (0%)5/40 (12.5%)15/40 (37.5%)
Lipofundin MCT0/34 (0%)3/34 (8.8%)12/34 (35.3%)
Most frequent serious events
Most frequent serious events
EventLipidemLipofundin MCT
Device related infectionInfections and infestations1/402/34
Abdominal painGastrointestinal disorders0/401/34
Device dislocatioinProduct Issues0/401/34
Intestinal pseudo-obstructionGastrointestinal disorders0/401/34
Stoma site infectionInfections and infestations1/400/34
AnaemiaBlood and lymphatic system disorders1/400/34
Device breakageProduct Issues1/400/34
Dermo-hypodermitisInfections and infestations1/400/34
Most frequent other events
Showing 10 of 37
Most frequent other events
EventLipidemLipofundin MCT
Alanine Aminotransferase increasedInvestigations3/400/34
DiarrhoeaGastrointestinal disorders3/400/34
InfluenzaInfections and infestations0/402/34
NasopharyngitisInfections and infestations0/402/34
HeadacheNervous system disorders1/401/34
ArthralgiaMusculoskeletal and connective tissue disorders0/401/34
LymphangitisInfections and infestations0/401/34
Back painMusculoskeletal and connective tissue disorders0/401/34
ParesthesiaNervous system disorders0/401/34
FatigueGeneral disorders0/401/34

Baseline characteristics

74 patients were enrolled for the study. However, 2 patients dropped out before any further intervention. Therefor these 2 patients were not included in the baseline analysis population.

Age, Continuous
Age, Continuous(years)LipidemLipofundin MCTTotal
Mean50.13 ± 15.8252.44 ± 15.5051.22 ± 15.60
Sex: Female, Male
Sex: Female, Male(Participants)LipidemLipofundin MCTTotal
Female162440
Male221032
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LipidemLipofundin MCTTotal
White353166
Black or African American101
Native Hawaiian/Other Pacific011
Missing224
Region of Enrollment
Region of Enrollment(participants)LipidemLipofundin MCTTotal
Netherlands437
Poland201636
Italy235
United Kingdom213
France101121
08

Study locations

9 sites
  • Hôpital Archet 2 - Unité de support nutritionnel
    Nice, France
  • Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
    Pierre-Bénite, France
  • Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
    Bologna, Italy
  • Radboud university medical center
    Nijmegen, Netherlands
  • Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
    Lodz, Poland
  • Stanley Dudrick's Memorial Hospital
    Skawina, Poland
  • Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
    Warsaw, Poland
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
  • University College Hospital London
    London, United Kingdom
09

References and documents

Publications

  • Klek S, Chambrier C, Szczepanek K, Kunecki M, Sobocki J, Wanten G, Pironi L, Schneider SM, Rahman F, Cooper SC, Calder PC, Gabe S, Forbes A. Safe and well-tolerated long-term parenteral nutrition regimen: Omega-3-fatty-acid-enriched medium chained/ long chained triglycerides emulsion. Clin Nutr. 2024 Dec;43(12):415-424. doi: 10.1016/j.clnu.2024.11.007. Epub 2024 Nov 7. PubMed 39581180 ↗
  • Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z. PubMed 31888740 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Jul 2022, 54 months.

Results were first posted in Jul 2025, 2 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2017
First posted
Sep 14, 2017
StartActual
Jan 8, 2018
Primary completionActual
Jul 19, 2022
CompletionActual
Jul 19, 2022
Results first posted
Jul 4, 2025
Last update
Jul 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03282955
Lead sponsor
B. Braun Melsungen AG
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jan 8, 2018
Primary completion
Jul 19, 2022
Completion
Jul 19, 2022
Results posted
Jul 4, 2025
Last update
Jul 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

B. Braun Melsungen AG →

Start the discussion