Efficacy and Safety of Primovist in Chinese Patients
Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
Participants who had been diagnosed or suspected by doctors to have focal liver lesions that
need further evaluation in order to make an accurate diagnosis. Participants would need to
have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further
information about the number and characteristics of the focal liver lesions.
Participants were invited to take part in this clinical study. The purpose of this study was
to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of
lesion detection and characterization, and tolerability in Chinese patients with known or
suspected focal liver lesions.
Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium
developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was
first approved in 2004 in Sweden followed by an approval in the European community, in
Switzerland and Australia in the same year.
Procedures:
Before entry into the study and after entry of the study a physical examination was
conducted, blood pressure and heart rate were measured, blood and urine samples were taken.
Current medications and medical conditions (including suspected pregnancy) and medical and
surgical history were elicited by doctors.
After entry into the study, participants were scheduled to have an MRI examination, which
lasted about 25-35 minutes.
During the MRI examination, an initial MRI scan without contrast was acquired which followed
by another MRI series after the intravenous administration of Primovist.
The following day participants were asked to return to the hospital for a follow-up safety
evaluation.
Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance
imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection
and characterization of focal liver lesions by providing better contrast between the focal
liver lesions and surrounding normal tissue. Primovist were shown to provide additional
information regarding existence, number and characterization (lesion or non-lesion, malignant
or benign) of these abnormalities.
Based on the experience with patients given Primovist, some adverse reactions were observed.
Most of undesirable effects were transient and of mild to moderate intensity. The most
commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and
headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population
were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).
All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye
disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms
including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension;
taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting;
palpitations, erythema, chest pain and back pain.
Coldness, warmth or pain at the injection site, injection site reaction, and injection site
accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to
shock may occur.
Post-marketing tachycardia and restlessness have been reported. As in the case of other
investigational drugs, there may also be unforeseen side effects.
Additional information concerning all Gadolinium- based contrast agents Primovist contains
the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic
systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents
(especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease
characterised by formation of connective tissue in the skin, which becomes thickened and
hard, sometimes leading to contractures and joint immobility. The clinical course is usually
progressive and currently no treatment is available. To date NSF has only been reported in
association with some Gd-containing contrast agents, but the role of these contrast agents in
the overall pathogenesis of the disease is still not completely understood.
No reports of patients with NSF after administration of Primovist® are known. The risk to
trigger NSF in risk patients with severe renal impairment is considered to be low for
Primovist® due to the low dose given and the additional excretion via feces. Furthermore the
participation of patients with severe renal impairment are excluded from this study.
In case the participants were suffering from renal insufficiency, they were told to tell
their doctors prior to application of the contrast agent. In case the participants
experienced any new alterations of the skin following the administration of the contrast
agent, they were told to contact their doctors as soon as possible after they had recognized
these symptoms.