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

MassBiologics

Status and phase

Terminated

Phase 2

Conditions

Hepatitis C Infection

Treatments

Drug: Sofosbuvir (Part 2)

Biological: MBL-HCV1

Drug: Telaprevir (Part 1)

Study type

Interventional

Funder types

Other

Identifiers

NCT01532908

MBL-HCV1-11-03

Details and patient eligibility

About

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.

Full description

Administration of Intravenous infusions of MBL-HCV1 (50mg/kg) human monoclonal antibody during the first 14 days post-transplantation: three infusions on day 0 (1-4 hours prior to the anhepatic phase, during the anhepatic phase, and 4-12 hours post-reperfusion). Daily infusions on days 1 through 7, weekly infusions on day 14 ± 2, day 21 ± 3, and day 28 ± 3, followed by biweekly infusions on day 42 ± 3 and on day 56 ± 3 if criteria for the stopping rule are not met. For those subjects electing extended treatment, the administration of additional infusions on day 70 ± 3 and day 84 ± 3 will be performed. Subjects receive an oral direct-acting antiviral (telaprevir in Part 1 and sofosbuvir in Part 2) starting no earlier than day 3 post-transplant and no later than day 7; dosing continuing through day 56 unless criteria for the stopping rule are met. Subjects who elect to receive extended study treatment for a total of 12 weeks continue telaprevir in Part 1 or sofosbuvir in Part 2 through day 84 ± 3.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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