161505 - Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD

• Research type

  Research Study

• Full title

  Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• IRAS ID

  224061

• Contact name

  Andras Nagy

• Contact email

  andras.nagy@baxalta.com

• Sponsor organisation

  Baxalta Innovation GmbH

• Eudract number

  2016-000374-37

• Duration of Study in the UK

  5 years, 5 months, 8 days

• Research summary

  Summary of Research
  The 161505 clinical trial is an extension study to the 161403 study. The study drug is made of two components Immune Globulin Infusion 10% with Recombinant Human Hyalauronidase rHuPH20, the brand name is HyQvia. It will be given to as a subcutaneous (SC) (under the skin) infusion to treat patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Roughly 149 patients will be enrolled.
  This is a Phase 3b clinical trial, the study drugs have already been tested in patients but further information will be collected. The study drug is already approved in many countries but neither have been approved for the treatment of CIDP but similar products are approved to treat CIDP. The study drug will be given as a maintenance treatment, which is a treatment given with the aim to stop a condition from coming back. The main purposes of this study is to check the study drugs prevent CIDP coming back and to check the long-term safety and Side-effects.

  This trial “open label” meaning the participant and doctor will know the treatment is what being received. All patients will get study drug there is no dummy drug called a “placebo”. It is expected patients will be involved in the study for up to 3 years. The study drugs will be administered at the study centre to the same schedule as the 1614043 study (either every 2, 3, o r 4 weeks). In addition patients will have approximately 4 study visits/per year i.e. 12 weekly

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Fsearch%253Fquery%253D161505%2FNBTI%2FstO2AQ%2FAQ%2F8249e9cc-b5d8-4116-b6e6-2a23485aa2f8%2F1%2Fj0JkpPIc4j&data=05%7C02%7Csheffield.rec%40hra.nhs.uk%7Cede856744be649a570b808dcaa4615df%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638572465193205404%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=9US0x9uRvyHY1YsgeVqSNvkIOnpCAXqVaJrZi5YCzP4%3D&reserved=0

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0309

• Date of REC Opinion

  5 Oct 2017

• REC opinion

  Further Information Favourable Opinion