Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden

  • STATUS
    Recruiting
  • End date
    Jul 17, 2022
  • participants needed
    204
  • sponsor
    FibroGen
Updated on 17 February 2021
Investigator
Charles Bradley, PhD
Primary Contact
Investigational Site (7.7 mi away) Contact
+74 other location

Summary

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.

Description

This study includes an Open-Label Lead in, a Double-Blind component and an Open-Label High Erythropoietin component. In each, there is an up to 42 days screen period followed by a treatment period of 52 weeks and a 4 week end of treatment assessment.

Details
Condition Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)
Treatment Placebo, FG-4592
Clinical Study IdentifierNCT03263091
SponsorFibroGen
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence
RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
Pre-transfusion hemoglobin of <= 10 g/dL
ECOG of 0-2 at screen
History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

Exclusion Criteria

Diagnosis of secondary MDS
Significant myelofibrosis (>2+fibrosis)
MDS associated with 5q(del) abnormality
Screen serum erythropoietin level > 400 mIU/mL (Double Blind); for Open- Label High Erythropoietin patients serum erythropoietin level must be >400 mIU/mL
Clinically significant anemia due to non-MDS etiologies
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note