NCT02628860

Brief Summary

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

6.3 years

First QC Date

February 5, 2015

Last Update Submit

April 27, 2020

Conditions

Pancreatic CancerAnemia

Keywords

ferric carboxymaltoseFerinject®pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Perioperative transfusion rate

    To evaluate reducing transfusion rate during perioperative period

    from preoperative baseline within the first 7 days after surgery

Secondary Outcomes (3)

  • Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications

    up to 4-6 weeks after surgery

  • Change of hematology parameters

    up to 4-6 weeks after surgery

  • Adverse event

    up to 4-6 weeks after surgery

Study Arms (1)

Ferinject

EXPERIMENTAL

Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50 Kg . Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride. Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.

Drug: Ferinject (Ferric Carboxymaltose)

Interventions

Ferinject (Ferric Carboxymaltose)DRUG

Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50 Kg . Study drug may be administered as IV drip infusion or IV undiluted bolus injection.

Also known as: Ferinject
Ferinject

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥19 years old
  • anticipating PD
  • preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
  • signed written informed consent

You may not qualify if:

  • a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
  • hypersensitivity to any component of the formulation
  • active severe infection/inflammation
  • history of transfusion, erythropoietin, \>500 mg intravenous iron administration within 4 weeks prior to screening.
  • history of acquired iron overload.
  • MCV \> 95µm3 or TSAT \> 35%
  • patients with preoperative Hb\<7 g/dl
  • pregnancy or lactation
  • decreased renal function (defined as creatinine clearance \<50 L/min/1.73m2calculated by eGFR(MDRD))
  • chronic liver disease or increase of liver enzymes (ALT, AST) \>5 times the upper limit of normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (9)

  • Park SJ, Kim SW, Jang JY, Lee KU, Park YH. Intraoperative transfusion: is it a real prognostic factor of periampullary cancer following pancreatoduodenectomy? World J Surg. 2002 Apr;26(4):487-92. doi: 10.1007/s00268-001-0254-6. Epub 2002 Feb 4.

    PMID: 11910485RESULT

  • Yeh JJ, Gonen M, Tomlinson JS, Idrees K, Brennan MF, Fong Y. Effect of blood transfusion on outcome after pancreaticoduodenectomy for exocrine tumour of the pancreas. Br J Surg. 2007 Apr;94(4):466-72. doi: 10.1002/bjs.5488.

    PMID: 17330243RESULT

  • Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5.

    PMID: 1990875RESULT

  • Kaplan J, Sarnaik S, Gitlin J, Lusher J. Diminished helper/suppressor lymphocyte ratios and natural killer activity in recipients of repeated blood transfusions. Blood. 1984 Jul;64(1):308-10.

    PMID: 6234037RESULT

  • Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function. III. Alterations in macrophage arachidonic acid metabolism. Arch Surg. 1987 Jan;122(1):56-60. doi: 10.1001/archsurg.1987.01400130062009.

    PMID: 3492188RESULT

  • Innerhofer P, Tilz G, Fuchs D, Luz G, Hobisch-Hagen P, Schobersberger W, Nussbaumer W, Lochs A, Irschick E. Immunologic changes after transfusion of autologous or allogeneic buffy coat-poor versus WBC-reduced blood transfusions in patients undergoing arthroplasty. II. Activation of T cells, macrophages, and cell-mediated lympholysis. Transfusion. 2000 Jul;40(7):821-7. doi: 10.1046/j.1537-2995.2000.40070821.x.

    PMID: 10924610RESULT

  • Ghio M, Contini P, Mazzei C, Brenci S, Barberis G, Filaci G, Indiveri F, Puppo F. Soluble HLA class I, HLA class II, and Fas ligand in blood components: a possible key to explain the immunomodulatory effects of allogeneic blood transfusions. Blood. 1999 Mar 1;93(5):1770-7.

    PMID: 10029607RESULT

  • Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.

    PMID: 6125797RESULT

  • Griffin JF, Smalley SR, Jewell W, Paradelo JC, Reymond RD, Hassanein RE, Evans RG. Patterns of failure after curative resection of pancreatic carcinoma. Cancer. 1990 Jul 1;66(1):56-61. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-6.

    PMID: 2354408RESULT

MeSH Terms

Conditions

Pancreatic NeoplasmsAnemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sang Jae Park, M.D

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch

Study Record Dates

First Submitted

February 5, 2015

First Posted

December 11, 2015

Study Start

January 1, 2014

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)