Ferring Pharmaceuticals (Switzerland) and MSD, known as Merck & Co., Inc. (USA), announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).
Each year, 14 million mothers are affected by PPH. As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09. Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.
CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH). Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.
If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.