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

• Status: Terminated
• Trial end date: 2015-08-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or sofosbuvir [part 2: an Hepatitis C virus NS5B polymerase inhibitor] in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection. There is an option for extended study treatment through 84 days if viral load is undetectable at day 56.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MassBiologics
• Treatments: Antiviral Agents; Sofosbuvir

Criteria

Inclusion Criteria:

• Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of genotype 1 undergoing liver transplantation from either a deceased donor or living donor.

• Patient or legal guardian/health care proxy must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.

Exclusion Criteria:

• Positive for hepatitis B surface Antigen

• Positive serology for HIV

• Pregnancy or Breastfeeding

• Previous history of any organ transplant

• Planned receipt of combined organ transplant (e.g. liver and kidney)

• Receipt or planned receipt of immune globulin (IVIG) within 90 days of enrollment

• Extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. Exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment

• Hepatocellular carcinoma with tumor burden outside of the Milan criteria

• Serum creatinine > 2.5 for > or = six months at the time of enrollment

• Personal or family history (first degree relative) of deep venous thrombosis or pulmonary embolism

• Receipt of liver allograft from HCV positive donor or Hepatitis B core antibody positive donor

• Receipt of liver allograft donated after cardiac death of donor

• Receipt of any antiviral agents (licensed or investigational) for hepatitis C virus within 30 days prior to liver transplantation, unless patient has documented detectable HCV RNA during this 30 day period

• Previous receipt of an HCV protease inhibitor (for subjects enrolling in Part 1:

telaprevir)

• Receipt of any other investigational study product within 30 days prior to enrollment

• Seizure disorder requiring anti-convulsant therapy

• Pulmonary arterial hypertension requiring sildenafil or tadalafil infusion (for subjects enrolling in Part 1: telaprevir)

• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study