Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C (MBL-HCV1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MassBiologics
ClinicalTrials.gov Identifier:
NCT01121185
First received: May 6, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether a human monoclonal antibody against Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in patients undergoing liver transplantation due to chronic HCV infection. The study will also determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in patients after transplant.


Condition Intervention Phase
HCV Infection
Liver Transplantation
Biological: MBL-HCV1
Other: 0.9% Sodium chloride Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double-Blind, Placebo Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBL-HCV1) in Hepatitis C Infected Patients Undergoing Liver Transplantation

Resource links provided by NLM:


Further study details as provided by MassBiologics:

Primary Outcome Measures:
  • Percentage of Subjects with Detectable Serum HCV RNA at Day 42 Post-Transplantation (Measured by Quantitative RT-PCR) [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined through Medical History, Physical Examination and Laboratory Evaluation [ Time Frame: Through Day 56 ] [ Designated as safety issue: Yes ]
  • Reduction in Serum HCV RNA at Day 3, 14, 28 and 42 Post-Transplantation (Measured by Quantitative RT-PCR) [ Time Frame: Through Day 42 ] [ Designated as safety issue: No ]
  • Reduction in the Proportion of Subjects with Histologic Evidence of Hepatitis Assessed by Batts and Ludwig Score on Day 42 Post-Transplantation Compared to Baseline [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points During the 56-Day Study Period [ Time Frame: Through Day 56 ] [ Designated as safety issue: No ]
  • Delay in Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation (Measured by Quantitative RT-PCR) [ Time Frame: Through Day 56 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBL-HCV1 Biological: MBL-HCV1
50 mg/kg MBL-HCV1, intravenous
Placebo Comparator: 0.9% sodium chloride Other: 0.9% Sodium chloride Placebo
0.9% sodium chloride, intravenous
Other Name: Normal Saline

Detailed Description:

This is a Phase 2, randomized, double-blind, placebo controlled study in Hepatitis C (HCV) infected patients undergoing liver transplantation. Chronically infected patients with HCV genotype 1a scheduled to receive a liver transplant from either a deceased or living donor who satisfy all study inclusion or exclusion criteria will be approached to participate. The study will be conducted in two parts to test a human monoclonal antibody against Hepatitis C (MBL-HCV1). In Part 1, sixteen eligible patients will be randomized 1:1 to receive 50 mg/kg MBL-HCV1 or 0.9% sodium chloride placebo intravenously. Eleven doses will be given during the first 14 days post transplantation. Patients will be evaluated through day 56 for safety and clinical outcomes that include measurement of anti-HCV antibodies, anti-drug antibody and HCV viral load. On study visit day 42, a liver biopsy will be performed for evaluation of hepatitis. Physical examination, vital sign measurements, emergence of adverse events and concomitant medication usage will be assessed at scheduled visits and as needed during the 56 day study period.

The Data Safety and Monitoring Board will perform a futility analysis after the first 16 patients have been enrolled and completed study follow-up through study visit day 42 post transplant. Based on the results of the interim analysis, the dose of MBL-HCV1 for part 2 of the study will be determined. Part 2 of the study will be conducted in the same manner as Part 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of genotype 1a 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 serology 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
  • History of extrahepatic malignancy and/or receiving chemotherapy within 90 days prior to enrollment with the exception of chemoembolization for hepatocellular carcinoma
  • Hepatocellular carcinoma with tumor burden outside of the Milan criteria
  • History of chronic renal insufficiency or creatinine > 2.5 for ≥ six months
  • Personal or family history 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 90 days prior to enrollment
  • Receipt of any other investigational study product within 30 days prior to enrollment
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121185

Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06504
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Methodist Healthcare Foundation
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
MassBiologics
  More Information

No publications provided

Responsible Party: MassBiologics
ClinicalTrials.gov Identifier: NCT01121185     History of Changes
Other Study ID Numbers: MBL-HCV1-10-02
Study First Received: May 6, 2010
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MassBiologics:
Hepatitis C virus (HCV)
Liver transplantation
Human Monoclonal Antibody

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014