Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C (MBL-HCV1)
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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 |
- 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 ]
- 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 |
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| 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 | |
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 29, 2012 |
| 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 Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013