NCT01532908View on ClinicalTrials.gov

Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

November 21, 2012

Primary Completion Date

August 27, 2015

Study Completion Date

August 27, 2015

Conditions
Hepatitis C Infection
Interventions
BIOLOGICAL

MBL-HCV1

50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56

DRUG

Telaprevir (Part 1)

Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56

DRUG

Sofosbuvir (Part 2)

One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56

Trial Locations (5)

10029

Mount Sinai Hospital, New York

63110

Washington University School of Medicine, St Louis

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Lead Sponsor

MassBiologics
All Listed Sponsors
lead

MassBiologics

OTHER

NCT01532908 - Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C | Biotech Hunter | Biotech Hunter