NT100(Response Study)

Read this carefully BEFORE you sign up, there is a much better alternative.

What is NT100?

NT100 is a new drug manufactured by Nora Therapeutics a company that specializes in fertility medications. The treatment is currently being studied as a means for improving pregnancy success rates in women who have been unsuccessful with in vitro fertilization (IVF) procedures or those with recurrent pregnancy loss. A new study called the Response study is testing this drug in the UK for the indication of recurrent pregancy loss.

NT100 is a variant of G-CSF, a naturally occurring substance in the body. The normal form (non-variant or wild-type) G-CSF is currently marketed under the name Neupogen (a drug that is approved for raising the white blood cell count in patients who have had chemotherapy or were born with a low white blood cell count),and now a bio similar drug called Granix is also available now that Neupogen has come off of patent.(Granix may be significantly less expensive than Neupogen.) Nora Therapeutics is trying to patent NT100, another very similar drug to Neupogen. Evidence generated by the study may earn NT100 approval by the U.S. Food and Drug Administration (FDA) as a treatment to assist in fertility treatments, but we expect the action of NT100 to be no different than that of Neupogen or Granix.

Should you participate in the Response Study?

Our opinion is that you should first have the most effective immunologic workup in order to try and diagnose the immune related issues causing the recurrent pregnancy loss. At this time , this testing is not being offered to patients in the Response Study. We have been using neupogen and performing this extensive immune testing for years and have more knowledge about its uses and indications than any other center in the World.

Prior to signing any consents for this study , you should call our center for a free consult to determine if you should first have a complete immune evaluation. If you require nuepogen therapy , we can prescribe treatment without the fear that you are receiving a placebo medication. At the current state of our knowledge on the use of neupogen , there appears to be no benefit to the patient to enroll in the study , as the study drug is readily available and we have an extensive knowledge base on its use.

We have found that in many of our patients that have required Neupogen there was an underlying immune issue that had previously failed to be diagnosed. The NT100 Study does not have a protocol in place to screen for these disorders and we believe in many cases treatment in the NT100 study may lead to "incomplete" treatment of the underlying issue and contribute to a failure of treatment. (miscarriage, failure to conceive, or late pregnancy complications such as preeclampisa or fetal growth restriction).

In the unfortunate case of another miscarriage for those in the NT100(Response) study, our extensive experience and expertise in immune testing and diagnosis also allows us to determine what additional or alternative treatments to Neupogen(NT100) may have been needed to prevent failure(failure is not just defined as inability to become pregnant but completing the pregnancy without complications in any trimester not just the first). For those that come immediately after a failure and even those currently pregnant from the study and remain on the treatment, we should be able to determine if you have received the placebo or the NT100, which will assist us in determining the correct treatment for the remainder of your current pregnancy or your next attempt at pregnancy. You should be aware that any testing done during the "study" phase may require your withdrawal from the study and we will not be able to participate in your care unless you notify your investigating doctor of our involvement.