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Study Design Services

Case Studies

Device-Based Treatment of Liver Disease

Infecting an estimated 170 million people worldwide, Hepatitis C Virus (HCV) is a leading cause of liver cancer, cirrhosis, and liver failure. While existing treatments of interferon and rabivirin can cure over 50% of patients with HCV, the treatment is expensive, difficult to tolerate, and not all patients are treatment candidates. Many of those within the large group of underserved patients with chronic HCV, suffer from fatigue, a leading cause of disability in chronic HCV patients, which is often associated with reduced quality of life. There are no approved therapies for HCV induced fatigue.

A privately held start-up was looking to qualify an innovative device-based treatment to reduce fatigue in HCV patients, to improve their quality of life.  The device sought to improve fatigue through daily treatments, which would occur in the patient’s home. The company selected Boston MedTech Advisors to devise its regulatory strategy, and Boston MedTech CRO to provide full service support for a pivotal clinical trial to evaluate the safety and efficacy of this treatment.

As the client company’s CRO and advisor, Boston MedTech worked with the company to develop a regulatory strategy and clinical roadmap, executed through a multi-center study, leveraging the feasibility study previously done by the company. Boston MedTech CRO assisted in protocol development for the two-arm, randomized, controlled, double-blind cross-over study, and identified early on the issue of compliance for the in-home trial. By developing and executing a remote patient monitoring system including home visits and web-based treatment tracking system, BMTA increased patient compliance to an unprecedented level of 95%, reducing the duration of study to the minimum required.  

Services provided by Boston MedTech CRO included selection of clinical sites, negotiation of agreements with the study sites and the PIs, budget management for the year-long study, development of all study documents, providing technical support and maintenance for the equipment, assembling and running the DSMB, conducting all required monitoring visits, designing the study database, providing data entry and data verification services, and identifying innovative statistical approaches for data analysis for this complex study.

Study was initiated following a review of the protocol with FDA, and concluded – on budget - following successful recruitment of subjects, enrollment and completion of the entire two-arm protocol.