Ferring Pharmaceuticals and Merck, through its Merck for Mothers initiative, 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).
The CHAMPION trial is studying whether Ferring’s investigational proprietary heat-stable formulation of carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum hemorrhage or PPH). Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH. These 10 countries include Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.
Each year, 14 million mothers are affected by PPH. As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-2009. 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 anemia.
The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth. Oxytocin requires refrigeration during shipping and storage to prevent degradation in temperatures above 8 C. Heat-stable carbetocin may remain active long-term in hot and humid climates, and in many low- and lower-middle-income countries, cold storage is difficult to achieve and maintain.
“Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,” said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favorable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”
“Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”
If the results of the CHAMPION trial are favorable, Ferring plans to seek registration of heat-stable carbetocin on a broad basis. 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.
“The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L. Gerberding, M.D., M.P.H., executive vice president & chief patient officer, Strategic Communications, Global Public Policy and Population Health at Merck. “Through Merck for Mothers, we provided our company’s scientific expertise and financial resources and ultimately, we hope to make a sustainable impact on the health of mothers, families and communities.”
About the CHAMPION trial
CHAMPION (Carbetocin Haemorrhage Prevention), the world’s largest clinical trial in postpartum hemorrhage, is being undertaken to compare the effectiveness and safety of heat-stable carbetocin to oxytocin in the prevention of postpartum hemorrhage after vaginal births. The trial conducted by the Human Reproduction Program (HRP) at the World Health Organization enrolled nearly 30,000 women in 10 countries including Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom. Heat-stable carbetocin was researched and developed by Ferring Pharmaceuticals and the CHAMPION trial was funded by Merck for Mothers.
Filed Under: Drug Discovery