Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy (FCM)
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|ClinicalTrials.gov Identifier: NCT02628860|
Recruitment Status : Unknown
Verified March 2017 by Sang-Jae Park, National Cancer Center, Korea.
Recruitment status was: Recruiting
First Posted : December 11, 2015
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Anemia||Drug: Ferinject (Ferric Carboxymaltose)||Phase 2|
Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).
Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
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)
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.
Other Name: Ferinject
- Perioperative transfusion rate [ Time Frame: from preoperative baseline within the first 7 days after surgery ]To evaluate reducing transfusion rate during perioperative period
- Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications [ Time Frame: up to 4-6 weeks after surgery ]To investigate the association between the number of participants with complications and hospital length of stay(days)
- Change of hematology parameters [ Time Frame: up to 4-6 weeks after surgery ]
change of hematology parameters value of Hb in g/dL,
- ferritin in ng/ml
- transferrin saturation in % (TSAT) after Ferinject® administration)
- Adverse event [ Time Frame: up to 4-6 weeks after surgery ]assessment of adverse effect with Ferinject® administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628860
|Contact: Sang Jae Park, M.Dfirstname.lastname@example.org|
|Contact: Sung Sik Han, M.Demail@example.com|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Contact: Sang Jae Park, MD 82-31-920-1640 firstname.lastname@example.org|
|Contact: Sung Sik Han, MD 82-31-920-1641 email@example.com|
|Sub-Investigator: Jung Nam Joo, Ph.D|
|Sub-Investigator: Sun Young Gong, M.D|
|Sub-Investigator: Sung Sik Han, M.D|
|Sub-Investigator: Young Woo Kim, M.D|
|Sub-Investigator: Woo Jin Lee, M.D|
|Sub-Investigator: Sang Myeong Woo, M.D|
|Sub-Investigator: Seung Duk Lee, M.D|
|Principal Investigator:||Sang Jae Park, M.D||Study Principal Investigator|