Three New Spanish-Coordinated Clinical Trials Launched
ECRIN is providing trial management support to three new projects coordinated by Spain: LIVERHOPE, HIVACAR, and ORTHOUNION.
LIVERHOPE aims to evaluate a novel therapeutic strategy for patients with cirrhosis based on a combination of rifaximin and simvastatin, targeting the main pathophysiological mechanisms of disease progression. LIVERHOPE will include two randomised double-blind trials to investigate the safety, tolerability and efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis in five EU countries. The expected impact is to halt progression to acute-on-chronic liver failure, the main cause of death, to decrease complications of the disease, to reduce hospital re-admissions, to improve cost-effectiveness of therapy. The LIVERHOPE kick-off meeting was help in Barcelona on 12 January.
The main goal of HIVACAR is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV (i.e., control of viral load to levels below the threshold of 50 copies/ml and maintenance of high CD4+ T-cell count after discontinuation of antiretroviral therapy) thanks to effectively targeting residual virus replication and viral reservoirs. In order to do so, the planned novel strategy is to successfully combine immune-based therapies, including therapeutic vaccines and broadly neutralizing antibodies with latency reversing agents, in a proof-of-concept phase IIa clinical trial. The HIVACAR launch meeting was held from 23 to 24 January.
ORTHOUNION, launched from 6 to 7 February, aims to assess clinically relevant efficacy of an autologous advanced therapy medicinal products (ATMP) with GMP multicentric production in a well-designed, randomised, controlled, three-arm clinical trial under GCP, versus bone autograft, gold-standard in fracture non-unions. A non-inferiority analysis will evaluate if cell dose can be lowered. ATMP has been authorised by the national competent authorities of the participating countries in three previous trials (REBORNE) and will be monitored by ECRIN to ensure quality and credibility of randomised clinical trial results.
LIVERHOPE has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 731875.
HIVACAR has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 731626.
ORTHOUNION has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 733288.